CognitrexCancerDigest

AbbVie’s Rova-T has failed yet another lung cancer trial, this time as a frontline treatment. But AbbVie didn’t regroup and point to its Rova-T programs in other treatment settings. It axed the drug, once and for all. The Big Pharma picked up Rova-T, a.k.a. Rovalpituzumab tesirine, in its $5.8 billion buyout of Stemcentrx in 2016. At the time, the drug was in a phase 2 study aimed at a quick FDA nod with the potential to net another $4 billion for Stemcentrx in milestone payments. Rova-T’s promise lay in targeting delta-like protein 3 (DLL3), which is expressed in more than 80% of tumors in patients with small-cell lung cancer (SCLC). The antibody-drug conjugate is designed to deliver a cytotoxic payload directly to DLL3-expressing cancer cells, while sparing healthy cells and reducing side effects. It carried hope for SCLC patients, who have few treatments outside of surgery and chemotherapy. Source: https://www.fiercebiotech.com/biotech/it-s-official-abbvie-dumps-rova-t-after-a...

The European Commission approved Tecentriq with Abraxane for people with metastatic triple-negative breast cancer that tests positive for a protein believed to help tumours to evade attack by the body's immune system, Roche said on Thursday. ZURICH: Roche 's Tecentriq has won European approval for use against a tough-to-treat breast cancer , helping the Swiss drugmaker to widen use of an immunotherapy that has so far been eclipsed in revenue terms by more-established rival medicines. The European Commission approved Tecentriq with Abraxane for people with metastatic triple-negative breast cancer that tests positive for a protein believed to help tumours to evade attack by the body's immune system, Roche said on Thursday. Tecentriq trailed rival immunotherapies Keytruda and Opdivo - produced by Merck and Bristol-Myers Squibb respectively - to market but has been racking up approvals. These include approvals for niche indications such as metastatic triple-negative breast ...

GlaxoSmithKline said an experimental multiple myeloma treatment has shown a meaningful response in patients that have run out of three previous treatment options, in a boost for the British drugmaker’s cancer drug business. Two doses of belantamab mafodotin helped subdue the disease in adults who had received three prior treatments for multiple myeloma, a cancer of the white blood cells, GSK said on Friday. The company intends to seek market approval and submit data from the trial to regulatory bodies this year. GSK sold its approved oncology drugs to Novartis in 2014, but has staged a comeback in cancer treatment with a deal to buy U.S. firm Tesaro for $5.1 billion last year and an agreement in February to pay up to 3.7 billion euros ($4.09 billion) to Germany’s Merck KGaA for the rights to a next-generation immunotherapy. “We are on track to file belantamab mafodotin later this year and continue to investigate how it could help even more patients with this disease,” GSK’s Chief Scie...

Amgen and Allergan plc announced positive top-line results from a comparative clinical study evaluating the efficacy and safety of ABP 798, a biosimilar candidate to Rituxan (rituximab), compared to Rituxan in patients with CD20-positive B-cell non-Hodgkin's lymphoma. The primary endpoint, an assessment of overall response rate (ORR) by week 28, was within the prespecified margin for ABP 798 compared to Rituxan, showing clinical equivalence. safety and immunogenicity of ABP 798 were comparable to Rituxan. This is the second of two studies intended to support regulatory submissions for ABP 798. The first study was conducted in patients with moderate-to-severe rheumatoid arthritis (RA) and met the primary endpoint of pharmacokinetic similarity. This RA study demonstrated clinical equivalence within the prespecified efficacy margin, and a similar safety and immunogenicity profile. "Today's results with ABP 798 demonstrate another positive development from Amgen's robust ...

FDA on Thursday approved Roche's cancer drug designed to target a tumor's genetic driver rather than the tissue where the tumor originated. FDA in a release said Roche's Rozlytrek is the third cancer drug to gain approval "based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated." Merck's Keytruda in 2017 became the first cancer treatment FDA approved to target a tumor's biomarker instead of the type of tissue from which the tumor originated. The approval marked a major step in treating cancer with precision medicine. FDA approves cancer drug to target cancer tumors with rare genetic mutations FDA granted Roche an accelerated approval for Rozlytrek to treat adolescents and adults who have solid cancer tumors with rare genetic mutations, called neurotrophic tyrosine receptor kinase (NTRK) gene fusions and who do not respond to other treatments. It is difficult to conduct tests for indivi...

Dr. Reddy's Laboratories Ltd. announced that it has launched Versavo (bevacizumab), a biosimilar of Roches Avastin in India, indicated for the treatment of several types of cancers (metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer). Dr. Reddy's Versavo is available in strengths of 100mg and 400mg single use vials. MV Ramana, CEO - India and emerging markets, Dr. Reddy's Laboratories, said, We regard the good health of our patients as our responsibility and are committed to ensure that they always have access to the medicines they need. The launch of Versavo is another step in that journey and helps strengthen our oncology portfolio. Dr. Raymond De Vr, global head, biologics, Dr. Reddy's Laboratories added Versavo will help improve access to high quality therapy at an affordable co...

The U.S. Food and Drug Administration today granted accelerated approval to Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments. “We are in an exciting era of innovation in cancer treatment as we continue to see development in tissue agnostic therapies, which have the potential to transform cancer treatment. We’re seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine,” said FDA Acting Commissioner Ned Sharpless, M.D. “Using the FDA’s expedited review pathways, including breakthrough therapy designation and accelerated approval process, we’re supporting this innovation in precision oncology drug development and the evolution of more targeted and effective treatments for cancer patients. We remain committed to encouraging the advancement of more targeted...

Natco Pharma is focusing on filing of cancer treatment drugs in China, the world's second largest pharmaceutical market, as part of its strategy to diversify business in various emerging markets amid headwinds in the US. Addressing shareholders in the company's Annual Report for 2018-19, Natco Pharma Chairman and Managing Director V C Nannapaneni said the company had foreseen imminent headwinds in the US market and had began diversifying its resources towards building businesses in new markets. Those investments are now reaping rewards, he added. "We are currently investing to further establish our presence in Australia, Singapore, China and South East Asian countries and are confident that our businesses in these markets will propel growth in the future," Nannapaneni said. In the near term, growth for the company would continue to be driven by markets like India, Brazil and Canada, he added. "As we continually balance our portfolio of products and growth in the...

Two months back, AstraZeneca and Merck made a strong case at the American Society of Clinical Oncology (ASCO) annual meeting that Lynparza should be the first PARP inhibitor approved to treat prostate cancer, with data showing the drug significantly delayed disease progression when added to Johnson & Johnson’s Zytiga. Now the Lynparza partners have a fresh set of data to back up their case, and this time it’s for use of the drug as a solo therapy. Merck and AstraZeneca said they have seen positive results from a phase 3 trial of Lynparza in men with metastatic castration-resistant prostate cancer and a mutation in a homologous recombination repair (HHR) gene. The men in the trial had progressed after receiving either Zytiga or Astellas’ and Pfizer’s Xtandi. The companies said there was a “statistically significant and clinically meaningful improvement” in progression-free survival among trial participants taking Lynparza over those on either Zytiga or Xtandi. They plan to present...