1 August 2024,London,UK:US FDA expands Jemperli (dostarlimab) plus chemotherapy approval - oncology

The US Food and Drug Administration (FDA) has expanded its approval of Jemperli to all adult patients with primary advanced or recurrent endometrial (uterine) cancer as the first and only immuno-oncology based treatment to show an overall survival benefit.Jemperli approval now includes MMRp/MMS tumours,which represent a majority of endometrial cancer cases.Jemporli plus chemotherapy demonstrated a significant and clinically meaningful 31% reduction in risk of death versus chemotherapy alone.GlaxoSmithKline announced today that the FDA has approved Jemperli (dostarlimab) in combination with carboplatin and paditaxel (chemotherapy) followed by Jemperli as a single agent for adult patients with primary or recurrent endometrial cancer.Said Hesham Abdullah,Senior Vice President,Global Head Oncology,R and D,GlaxoSmithKline:We are thrilled this option is now available for more patients in the US,including the 70-75% with MMrp/MMS tumours whose treatment options have been limited.*Press release by GlaxoSmithKline and edited by Andrew Taylor*GlaxoSmithKline plc (LSE/NYSE:GSK)

Princess of Wales gives rare update after cancer diagnosis - YouTube - oncology

with Boris Sanchez,Brianna Keilar,Dr.Sanjay Gupta and Kate Williams Takeaways:The illness is more serious than originally thought.There is much uncertainty involved.It may not be possible for Princess Catherine to carry out planned events,Buckingham Palace said.

Merck Expands Oncology Portfolio

On 9 December 2019,New Jersey-based pharma titan Merck announced it is acquiring biopharmaceutical prospect ArCule,Inc. for 20 dollars a share,or about 2.7 billion dollars.ArCule's lead investigational candidate,ARQ 531,is an oral medication in a phase 2 dose expansion study for the treatment of B-cell malignancies (leukemia).
ARQ 531 is a highly selective, reversible inhibitor that,in early clinical trials, demonstrated a manageable safety profile and early signs of anti-tumour activity for the treatment of patients with relapsed or refactory chronic lymphocytic leukemia (CLL) and Richter's Transformation.*
ArQule CEO Paolo Pucci said:
With this agreement,ArQule's pipeline will benefit from Merck's vast capabilities and determined engagement to benefit the patients who we have always strived to serve.*
ArQule's discovery efforts are focused on the identification and development of novel kinase inhibitors, the company noted.iAll four of its drug candidates are in targeted, biomarker-defined patient populations.*
Merck&Co Inc (MRK), ArQule Inc (ARQC)

Pfizer Expands its Oncology Team by Acquiring Array BioPharma

Already a leader in the treatment of prostate and breast cancer,Pfizer,the world's largest pharmaceutical company,has further enlarged its oncology portfolio by completing its acquisition of Array BioPharma,Inc.,the company announced on 30 July 2019.This will advance breakthrough science for the discovery,development and commercialisation of targeted small molecule medicines to treat cancer and other diseases of high unmet need,Pfizer said.*
Array's portfolio included the approved combined use of BRAFTOVI (R) and MEKTOVI (R) for the treatment of two forms of unresectable or metastatic melanoma skin cancer,with significant potential for long-term growth with expansion into additional areas of unmet need.The combination is also being investigated as a potential first-in-class combination for the treatment of BRAF-mutant metastatic colorectal cancer (mCRC),based on interim results the company feels are compelling from the pivotal Phase 3 BEACON trial,according to Pfizer.They believe this application has industry-leading potential.*
Pfizer says it will maintain Array's operations in Cambridge,Massachusetts;Morrisville,North Carolina;and Boulder,Colorado.Array is now a wholly-owned subsidiary of the New York-based pharma titan.The all-cash deal had a value of around 11.4 billion dollars.*
Pfizer Inc (PFE)

Pfizer will access Array's approved cancer drugs in $11 billion deal

Pfizer Seeks Quick Profits From Cancer Drugs

The world's largest drugmaker,Pfizer,has purchased Medivation for 14 billion dollars,or about 81.50 a share.It's expected to be immediately accretive,adding about .05 a share in the first full year after close with additional accretion and growth anticipated thereafter,Pfizer said.It may vault the New York-based firm into a leading position in oncology.*
The addition of Medivation will strengthen Pfizer's Innovative Health business and accelerate its pathway to a leadership position in oncology,one of our key focus areas,which
we believe will drive greater growth and scale of that business over the long-term,said Pfizer CEO Ian Read.*
The big prize for Pfizer was Medivation's drug XTANDI,an androgen receptor-which blocks multiple steps in the androgen reception signaling pathway within the tumour cell of advanced metastatic prostrate cancer,XTANDI has generated about 2.2 billion in worldwide net sales the past four quarters.Other Medivation prospects in the pipeline include two development stage oncology assets,tulazuparib for breast cancer and pidilmizumab for large B cell lymphoma and other blood cancers.*
Cancer is the second leading cause of death in the US and in the top 10 of killers worldwide,Pfizer pointed out.*
Meivation (MEDI);Pfizer (PFE)

MedImmune and 3M Partner in Cancer Drug Research

MedImmune,the biotech subsidiary of British pharma titan AstraZeneca,and 3M Drug Delivery Systems announced a research collaboration on 25 September 2015.It is focused on developing nextgen toll-like receptor agonists,which are agents that activate innate immune cells and enhance the visibility of cancer tumours.MedImmune has licensed MEDI9197 from 3M,which the US FDA recently accepted for an investigational drug application,allowing a Phase I study on its safety and tolerability as a potential treatment for solid tumour patients.*
Such TLR agonists activate antigen presenting cells such as dendritic cells,enhancing the visibility of a tumour to the immune system.MEDI9197 has been designed to activate a broad range of innate immune cells,leading to a more robust adaptive immune response.
Preclinial studies show MEDI9197 may inhibit tumour growth of both the injected and distant lesions in multiple types of cancer,including melanoma skin cancer.It is designed for intratumoural injection,allowing the compound to be retained in the tumour and provide specific immune activation,enhancing its safety and tolerability.*
MEDI9197 adds a unique mechanism to our growing portfolio,and supports our strategy of maximising anti-tumour immunity through scientifically rational combinations,said MedImmune Sr. Vice President and Head of Research Yong-Jun Liu,PhD.*
Everyone here at 3M's Drug Delivery Systems is very excited to collaborate with MedImmune,a world leader in cancer immunotherapy,according to Cindy Kent,President and General Manager of 3M DDS.We're very pleased with the progression of MEDI9197 to the clinic.*
Under the deal,MedImmune will be responsible for the clinical development and strategy for MEDI9197.3M will continue to develop more TLR agonists in oncology and other therapy areas,with MedImmune holding exclusive rights to conduct research on new molecules resulting from the collaboration,and to determine which to progress to clinical development.
MedImmune will make an upfront payment to 3M and must make developmental milestone payments for MEDI9197,as well as provide research funding to 3M.*
MedImmune is based in Gaithersburg,Maryland and is best known for its Flu-Mist influenza vaccines and its pediatric vaccine Synagis,which prevents the serious respiratory disease RSV.3M is a Saint Paul,Minnesota-based multinational corporation with 11 lines of business.It is famous for products such as the iconic Scotch Tape and Post-It Notes.*
AstraZeneca (AZN),3M (MMM)

Pfizer,Cellectis Ink Cancer Immunotherapy Pact

Pfizer,the world's largest pharmaceutical company,has signed a deal with French biotech firm Cellectis to develop and commercialise CAR-T immunotherapies in the field of oncology directed at several targets.Cellectis' CAR-T technology utilises engineered T-cells from a single donor for use in multiple patients,rather than engineering a patient's own T-cells to target tumour cells.*
Cellectis' CAR-Ts are off-the-shelf products which can be industrialised and standardised.They may be shipped in advance and would be accessible to cancer centers all over the world without the need for a local CAR-T processing facility,which is an enormous advantage.*
Cellectis plans to open a US site for this collaboration with New York-based Pfizer.Cellectis CEO Andre Chulika,PhD,said we look forward to working closely with the team at Pfizer on researching and developing novel CAR-T therapies that could potentially change the way cancer is treated.
Mikael Dolsten,MD,PhD,Pfizer President of R&D,added that combining the innovation and scientific expertise of Cellectis with Pfizer's deep oncology and immunology experience creates a world-class partnership designed to deliver a new generation of CAR-T immunotherapies for cancer patients with urgent medical needs.*
Cellectis will receive an upfront payment of 80 million dollars plus R&D costs.It will also receive development,regulatory and commercial milestone payments of 185 million per Pfizer product,as well as tiered roylaties on net sales.Pfizer will also purchase about 10% of Cellectis capital through newly issued shares of Cellectis,pending shareholder approval.*
Pfizer(PFE),Cellectis(ALCLS:EN Paris)

Kellys Thankful as Cancer Treatment Ends

Buffalo Bills great Jim Kelly has completed his six weeks of treatment for the recurrence of oral cancer.The NFL football star got his last dose of radiation Wednesday,and finished chemotherapy last week.The radiation was particularly painful,causing him to lose the skin from the roof of his mouth.He had to be fed through a tube.
His wife,Jill Kelly,tweeted the following:
At 1 pm today!IT IS FINISHED!
GLORY TO GOD!!!!
DONE!
She went on to tweet:
High Fives.Tears.And A LOT OF THANKS AND PRAISE!!!!
Again,THANK YOU FOR PRAYING!*
Next will be two to three months of assessment to deteremine if more surgery will be needed.Jim underwent his first operation last June.The squamous cell carcinoma returned and started to spread up his orbital nerve.
This blog will stay on the story.

New Study:Pancreatic,Liver Cancer Deaths on the Rise

The list of most deadly cancers in the US will change over the next 16 years,a new study published in the peer-reviewed journal Cancer Research projects.Today,the top three killers are lung,breast cancer for women/prostrate cancer for men,and colorectal cancer.By 2030,the study funded by the Pancreatic Cancer Action Network found that lung,pancreatic and liver cancers will be the top three causes of cancer death.The top diagnoses in 2030 are predicted to be lung,breast/prostrate,thyroid,melanoma and uterine cancers.
The projections for deaths from pancreatic and liver cancers are startling,said Lynn Matrisian,PhD,MBA,vice president of scientific and medical affairs at the PCAN.This study is a call to action to the scientific and clinical communities,as well as the population at large,to increase attention,awareness,and ultimately progress in the fight against pancreatic cancer.*
The new estimate considered two factors:the demographic trends of an aging population and the growing population of minorities,some of whom are more susceptible to certain cancers;and the changes in the average annual percentages of cancer incidence and deaths related to better screening and prevention on the one hand,and the prevalence of smoking and viral infections on the other.*
Pancreatic cancer is difficult to diagnose because access and imaging are limited by the location of the pancreas in the body.As well,it is difficult to treat because the tumours are surrounded and infiltrated by dense connective tissue that is believed to impede drug delivery.Data also suggest a tendency for the tumours to metastisise early in the course of the disease.Add to that the fact that less than 20% of the tumours are operable.*
The PCAN aims to double pancreatic cancer survival by 2020 through heightening awareness,raising funds for comprehensive private research,advocating for dedicated federal research to advance early diagnostics,better treatments and increase the chances of survival.

Jim Kelly Speaks Out on Cancer,Buffalo Bills Sale

NFL Hall of Fame quarterback Jim Kelly is a man fighting two battles at once.One is against the agressive oral cancer that threatens his life;the other is against the commercial interests in Ontario,Canada or elsewhere that may buy and eventually relocate his beloved Buffalo Bills,who are for sale following the death of founder and owner Ralph Wilson.In a statement released Thursday by his company,Jim Kelly,Inc.,Kelly said this cancer has been rough.It's hurt really bad and the treatments have kicked my butt.But my faith in God is strong and I'm back home in Buffalo working with a good team of doctors.I'm not out of the woods by any means,but we think the treatments are going well and I know I'm going to beat this.*
In an interview with The Buffalo News,Jim went into considerable detail about his struggles.It just seems like you're falling apart,the Western New York hero said.I went two weeks without eating.No tastebuds,no nothing.I wasn't getting any nutrition.Finally they had to put a feeding tube in.The radiation is burning my mouth.I have no skin on the roof of my mouth,but I'm getting through it.I've had such a supporting cast,not only from my family,but from Western New York-and all over the world.That surprised me.I have eight more radiation treatments and one more chemo treatment left.
I've gotten a number of emails from people who have been through the same thing with suggestions on how to deal with it.That helps.I fight every battle every day.I'm not scared to die.I know my tomorrows are going to be better than today.I know I'm going to see my late son again.
I still have so many things I've got to do-making sure the Bills stay in Buffalo.I'm battling,but it's not the battle I want to fight right now.I'm trying to do all I can right now.
Keep voicing your opinion.Whoever the new owner is,Western New York has to be the destination.Donald Trump is excited.We should know in the next six months who the players are,a very alert and determined Jim Kelly told sports writer Mark Gaughan from his black leather rocker with a red pillow.

Drug Companies Swap Units,Join Forces

Two pharma titans,GlaxoSmithKline and Novartis,are entering into a complex 25 billion dollar transaction.Novartis,based in Geneva,Switzerland,is buying GSK's oncology unit for 14.5 billion dollars;at the same time,Britain's GSK is buying Novartis' vaccine unit.Finally,the two firms are forming a joint venture that combines their over the counter drug businesses.
Today we announced we are focusing on our pharmaceutical,eye care,and generics businesses,said Novartis CEO Joseph Jimenez.We're gonna add probably one billion people on earth,and 50% of them will be over 50.It's gonna take innovation to deal with it.We've got these powerhouses that fit exactly with the demographic changes for the next 20 years-for example,GSK's two drugs for metastatic melanoma.
I believe increased technology is gonna allow new targets in cancer that we've never seen before.We're at the beginning of having new tools to combat this disease like never before.This deal with GSK changes the financial profile of Novartis,increasing our operating margin significantly.The whole portfolio review was to allow us to have great strength in that new world.I'll be able to feed these big engines a lot more.We're generating better leverage than we have in the past,explained Mr.Jiminez,who is an American.*
In addition,Novartis is selling its animal health business to Eli Lilly.Even when the deal with GSK is completed,Novartis will still be open to more bolt-on acquisitions that benefit its three lines of business.*
Novartis(NVS),Eli Lilly&Co(LLY),GlaxoSmithKline(GSK)

Multiple Myeloma:What Tom Brokaw Has

The well-known NBC Newsman and author Tom Brokaw,72,recently revealed he is being treated for multiple myeloma.It is a type of blood cancer in which abnormal plasma cells accumulate in the bones and bone marrow,where they can interfere with the production of blood cells and damage or fracture bones,as well as produce M proteins that damage the body.Plasma cells are white blood cells that produce antibodies which help the body fight infection.In multiple myeloma,these cells can multiply uncontrollably in several bones,causing a range of problems.Progressive MM is a terminal illness,but can be fought off for a number of years.The four year survival rate is up to 60% on the latest drug regimen.One doctor described it as being similar to having diabetes for many of his patients.*
Multiple myeloma has no known cause,but there are a number of risk factors,such as being over 65;an African American;a male;and having a family history of the disease.About 22,000 Americans a year are diagnosed with it.It may be detected during routine blood and urine tests,or a patient may present with such symptoms as bone fractures,back pain,infections,nosebleeds or anemia.Diagnosis and staging is achieved with more blood and urine tests,x-rays,CT scans,PET scans and MRI,and most definitively by needle biopsy.*
Complications of MM may include kidney failure,bone pain and fractures,weakness,bleeding,infections,hypercalcemia-calcium leaking into the bloodstream from damaged bones-spinal cord compression and neuropathy.*
This cancer can be without symptoms for years or may require immediate treatment.The treatments range from oral and IV chemotherapy,to radiation and stem cell transplants,with their attendant side effects.Clinical trials for new treatments are also a possibility for MM patients.*
As with other cancers,being hopeful and staying as active as possible for as long as possible is a wise course.Mr.Brokaw is said to be responding well to treatment and continuing with his projects.

MedImmune,Hopkins Sign Research Pact

An R&D company and a research university have joined forces in the quest for new treatments for a number of serious illnesses,such as cancer,rheumatoid arthritis and infectious diseases.MedImmune,the Gaithersburg,Maryland biotech firm that is a subsidiary of pharma titan AstraZeneca,and Baltimore's The Johns Hopkins University signed the five year,6.5 million dollar research agreement on 11 December.*
The broad-scale,long-term partnership calls for both institutions to contribute funding,personnel and materials to the joint efforts and training programs.We believe this significant collaboration with JHU will create a new standard in how academia and inustry can work together,said Dr.Bahija Jallal,executive vice president at MedImmune.Our partnership with this prestigious research university will leverage each organisation's strength;advance research in critical therapeutic areas;and strengthen Maryland's presence as a growing hub in the bioscience industry.*
We are excited about the opportunity to collaborate with MedImmune researchers to accelerate the development of new therapies to treat a variety of serious diseases such as multiple sclerosis;rheumatoid arthritis;chronic obstructive pulmonary disease;and certain types of cancer,said Landon King,executive vice dean of The Johns Hopkins University School of Medicine.We believe that by working together to leverage the strength of each organisation,we can make significant advances.*
MedImmune focuses on the discovery,development and commercialisation of small molecule and biologic prescription medicines,pioneering innovative research and exploring novel pathways across its key therapeutic areas.It is best known for its vaccines FluMist and Synagis(R),which helps prevent respiratory syncytial virus infections in infants.*
AstraZeneca(AZN)

Pfizer Breast Cancer Drug Gets Breakthrough Designation

A Pfizer investigational compound,palbociclib,an oral drug,has received Breakthrough Therapy designation by the FDA for the potential treatment of patients with a form of breast cancer.The designation expedites the development and review of the compound,as it is intended to treat a serious or life-threatening disease and preliminary evidence indicates the drug may demonstrate substantial improvement over existing therapies.
Pfizer has initiated a Phase 3 study evaluating palbociclib in combination with letrozole versus letrozole alone as a first line treatment for post-menopausal patients with ER+,HER2- locally advanced or metastatic breast cancer.The study is currently open and enrolling.
Preliminary Phase 2 data show that women treated with the combination of palbociclib with letrozole achieved statistically significant improvement in median survival compared to those treated with letrozole alone(26.1 months versus 7.5 months.)
Palbociclib is an inhibitor of cyclin dependent kinases,or enzymes that serve as on and off switches in tumour cells.The drug was shown to inhibit cell growth and supress DNA replication.Pfizer,the world's largest pharmaceutical company,is also investigating the drug's potential for treating other cancers.
Pfizer(PFE)

GlaxoSmithKline Submits New Melanoma Therapies

GlaxoSmithKline has submitted a Marketing Authorisation Application to the European Medicines Agency for trametininb as a monotherapy,and in combination with dabrafenib,for adult metastatic melanoma with a BRAF V600 mutation.The EMA granted GSK's request for accelerated assessment of the application.
The application contains data from two clinical trials of the therapies.
GSK initiated a randomised study early in the development programme to ascertain whether the combination therapy could circumvent resistance to single agent anti-BRAF melanoma therapy and were encouraged by trial results,said Dr.Rafa el Amado,Head of Oncology R and D.We are planning further submissions based on these data in the US and other countries in the coming months.
GSK had submitted applications for dabrafenib monotherapy to the EMA,and for trametinib monotherapy  to the US FDA,for BRAF V600 metastatic melanoma in August 2012.
Melanoma is the deadliest form of skin cancer and even kills numerous young people annually.
GlaxoSmithKline is one of the world's leading pharmaceutical and healthcare companies.London-based,it employs over 97,000 in more than 100 countries.
GlaxoSmithKline(GSK)

Pfizer Leukemia Pill Approved

Pfizer,the world's largest pharmaceutical company,has announced FDA approval of its new oral medication BOSULIF(R) for adults previously treated for chronic myelogenous leukemia,or CML,with the Philadelphia chromosome abnormality.There will be an estimated 5400 cases of CML diagnosed in 2012,resulting in 610 deaths.
Bosulif is described as an important new addition to the CML treatment landscape by a Pfizer lead investigator,Jorge Cortes,MD,professor of medicine at the University of Texas MD Anderson Cancer Care Center in Houston and Chief,CML Section,Department of Leukemia.Bosulif is one of a series of CML drugs called tyrosine kinase inhibitors that inhibit production of the tyrosine kinase enzyme by the bone marrow.They are based on a better understanding of the molecular basis of CML.
In clinical trials,about 55% of patients previously treated with other CML drugs returned to normal blood counts within the first 48 weeks of treatment with Bosulif,with a major response to treatment of at least 18 months.Novartis' GLEEVEC(R) is one of the main first line treatments for CML.
Up to 26,000 Americans are living with CML today.An unmet need remains for many CML patients,Dr.Cortes pointed out.Bosulif offers a distinct adverse event profile and a convenient once-daily dosing regimen,said Marc Rothenberg,MD,Pfizer vice president of Clinical Development and Medical Affairs.
Although it cannot be described as being a cure,Bosulif is indeed another step forward in the treatment of chronic myelogenous leukemia.
Pfizer(PFE),Novartis AG(NVS)

Health Uncle:What Are Moles-and when they should be evaluated

Moles are concentrations of melanocytes,the cells that give your skin its color.They may be flat or raised.Normal moles are evenly shaped and colored.A mole with irregular borders;a size greater than a pencil eraser;an uneven shape;or more than one color or shade is atypical.Any mole that has changed,looks weird or suddenly appeared if you are over 40,should  be examined by a health professional as soon as possible.In rare cases,moles can be precancerous or cancerous.
Cancerous moles are called malignant melanomas.They are a kind of tumor of the skin.Some melanomas metastasize slowly;but others can spread rapidly to other organs,often with fatal consequences.Young people can get and die from malignant melanomas.
Melanomas are diagnosed by biopsy.The suspicious mole is normally removed in a doctor's office.Mole removal is one of the most common surgeries.It only takes about ten minutes and is done under local anesthesia.The tissue will be sent to a lab for analysis.If the mole is cancerous,it must be staged,or assessed to see if it has spread.If it is superficial,no further treatment is required.If it has spread,an oncologist,or cancer specialist,will draw up a treatment plan following tests to definitively stage the cancer.Treatment of these more advanced melanomas may involve more surgery,radiation and chemotherapy of various types,depending on the patient's situation.
Exposure to ultraviolet radiation and heredity are significant factors that predispose to developing malignant melanomas.If any moles are worrying you,don't hesitate to have them examined.Remember,they don't have to be grotesque to be dangerous.

MedImmune's Oncology Portfolio Advances

MedImmune,the biologics business of British pharma titan AstraZeneca,is perhaps best known for its FluMist product,but it is also quite active in oncology innovation.They are using insights and understanding of cancer to discover breakthrough biologic therapies that can be used to treat specific cancers for the individual patient,according to Jerry McMahon,PhD,Senior Vice President and Oncology Innovative Medicines Unit Leader.
MedImmune's pipeline is focused on eliminating cancer cells in more effective and targeted ways.They are currently researching their products MEDI-575,an antibody with promise in treatment of solid tumors;and the immunotoxin moxetamomab pasudotox(CAT 8015),which is being evaluated for therapeutic potential against certain leukemias.
These are early phase studies,but MedImmune is excited about the oncology portfolio's progress and looks forward to advancing oncology products into expanded clinical studies in the near future,Dr.McMahon indicated.
MedImmune,based in Gaithersburg,Maryland,employs about 3500 people worldwide.Jerry McMahon,who assumed his position in October,received a doctorate in Biochemistry and Genetics from Rensselaer Polytechnic Institute in Troy,New York.
AstraZeneca(AZN)

From Thousands To Millions:The Jake Gittlen Cancer Research Foundation

The Jake Gittlen Cancer Research Foundation has grown fron raising 2500 dollars to a total well into the millions.Founded by Warren Gittlen as a memorial golf tournament to honor his father,who had died of cancer in 1970,the foundation funds oncology research at Penn State's Hershey Medical Center.It strives to recruit the top 10% of researchers,continuing to derive income from the golf tournament,the largest fund-raising amateur golf tournamnet in the U.S.It also receives funding from corporate sponsors-especially Giant Food Stores,which has donated over 5.4 million dollars over 28 years.Other sponsors include Giant vendors such as PepsiCo,Procter&Gamble,Clorox and Kraft Foods.
The foundation has raised more than 14 million to date.Its funds have been used to develop techniques and materials used in production of HPV vaccines such as Merck's Gardasil,a major preventitive of cervical cancer.This year,Gittlen Cancer Awareness Bracelets may be purchased for 10.00.The colorful beaded bracelets are handmade and show your support for cancer research,and all of the proceeds go to the Jake Gittlen Cancer Research Foundation.The bracelets may be purchased by emailing asgwmg@verizon.net.
Giant Food Stores operates hundreds of supermarkets in the Mid-Atlantic region.It is a brand of Dutch retailer Ahold.
Ahold(AHONY),Merck(MRK)