CognitrexCancerDigest

AstraZeneca and MSD Inc, announced further positive results from the phase III PROfound trial of Lynparza (olaparib) in men with metastatic castration-resistant prostate cancer (mCRPC) who have a homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new hormonal agent (NHA) treatments (e.g. enzalutamide and abiraterone). Results from the trial showed a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS) with Lynparza versus enzalutamide or abiraterone in men with mCRPC selected for BRCA1/2 or ATM gene mutations, a subpopulation of HRR gene mutations. The phase III PROfound trial had met its primary endpoint in August 2019, showing significantly improved radiographic progression-free survival (rPFS) in men with mutations in BRCA1/2 or ATM genes, and had met a key secondary endpoint of rPFS in the overall HRRm population. Jose´ Baselga, executive vice president, oncology R&D...

Shilpa Medicare Limited has launched the Indian branded generic of Dasatinib, an anti-cancer drug with a brand name 'DASASHIL'. DASASHIL is first branded generic anticancer drug with all dosage strength 20/ 50/ 70/ 100 mg tablets which is used for the treatment of chronic myeloid leukaemia (CML). Current, monthly therapy cost of innovator is approximately 1.65 lacs. With the launch of DASASHIL, monthly cost of treatment will be reduced drastically to Rs. 6440. DASAHIL will revolutionise the treatment by ensuring to make therapy available for more Indian patients due to increased affordability. The products are being manufactured and supplied from the state-of-the-art US-FDA approved manufacturing facility. Today, there are around 10,000 to 15,000 new patients of CML in India, which can be benefited by DASASHIL tablets. Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=123671&sid=2

Dr Reddy's Laboratories on Monday said it has launched blood cancer drug Invista in the country. The company's product is a formulation of Dasatinib that is bioequivalent to the innovator brand, Dr Reddy's Laboratories said in a statement. Patent on Dasatinib is owned by Bristol-Myers-Squibb. The Indian patent has expired on April 12, 2020. Invista, which is available in strengths of 50, 70 and 100 mg tablets, is indicated for the treatment of primarily Chronic Myeloid Leukemia (CML). CML is a type of blood-cell cancer that begins in the bone marrow. The median age of the patients in India is a decade earlier than the west, and every year about nine thousand new patients are diagnosed in the country. "The development and launch of Invista is a significant step forward in improving access to medicines at an affordable price for CML patients in India," Dr Reddy's Laboratories CEO, Branded Markets (India and Emerging Markets), M V Ramana said. Source: https://ww...

Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck's anti-PD-1 therapy. The application seeks accelerated approval of KEYTRUDA monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) ≥10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 16, 2020. "From the start, biomarker research has been a critical aspect of our clinical program evaluating KEYTRUDA monotherapy," said Dr Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. "TMB has been an area of sci...

AstraZeneca’s Imfinzi (durvalumab) has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide). The approval by the Food and Drug Administration (US FDA) was based on positive results from the phase III CASPIAN trial showing Imfinzi in combination with SoC platinum-etoposide demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus SoC alone. SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy. Dave Fredrickson, executive vice president, Oncology Business Unit said, “The US approval of Imfinzi brings a new medicine to extensive-stage small cell lung cancer patients in urgent need of new options. Imfinzi is the only immunotherapy to show both a sig...