The U.S. Supreme Court will not take up Amarin Corp. plc’s appeal of a September Federal Circuit decision that opened the door for generics of the company’s fish oil-derived cardiovascular drug, Vascepa (icosapent ethyl), to enter the U.S. market.
Bristol Myers Squibb Co. (BMS) and Eisai Co. Ltd. inked a potential $3.1 billion agreement to co-develop and co-commercialize the antibody-drug conjugate (ADC) MORAb-202 for advanced solid tumors. Eisai’s first ADC, MORAb-202 pairs the company’s anti-folate receptor alpha (FRα) antibody with the Tokyo-based firm’s anticancer agent eribulin using an enzyme cleavable linker. It is characterized as a potential best-in-class candidate and is under investigation for tumors that include endometrial, ovarian, lung and breast cancers in two studies: a phase I effort in Japan and a phase I/II experiment in the U.S. The companies plan to enter the registrational stage of development as early as 2022.
Bristol-Myers Squibb Co. has released top-line phase III results from its CAR T therapy Breyanzi (lisocabtagene maraleucel) that could support its use earlier in patients with refractory large B-cell lymphoma, outperforming standard stem cell transplant therapy.
Bristol Myers Squibb Co. said the FDA has approved Zeposia (ozanimod) as the first and only oral sphingosine 1-phosphate (S1P) receptor modulator for the treatment of ulcerative colitis (UC). The medicine, first FDA-approved in March 2020 for certain adults with multiple sclerosis, can now be used to treat patients with moderately to severely active UC.
CEO David Epstein said Black Diamond Therapeutics Inc. was “delighted” with phase I data testing BDTX-189 in advanced solid tumors harboring EGFR or HER2 alterations, but Wall Street seemed less so. Shares (NASDAQ:BDTX) closed at $13.93, down $8.30, or 37%.
Building on a deal first struck in 2019, artificial intelligence (AI) specialist Exscientia Ltd. has agreed to take responsibility for a multitarget drug discovery collaboration with Bristol Myers Squibb Co. that could be worth more than $1.2 billion in all. The expanded collaboration, first established with BMS-acquired Celgene Corp., includes $50 million in up-front funding, up to $125 million in near to mid-term potential milestones, plus additional clinical, regulatory and commercial payments. It remains focused on small-molecule drug candidates in areas including oncology and immunology.
The anti-TIGIT bispecific antibody AGEN-1777’s preclinical status didn’t stand in the way of Bristol Myers Squibb Co.’s whopper deal with Agenus Inc., which is collecting $200 million up front and as much as $1.36 billion in potential milestone payments in trade for development and commercial rights to the Fc-enhanced compound.
While acknowledging the net health benefit over standard of care in heavily pretreated multiple myeloma patients, CAR T-cell therapies Abecma (idecabtagene vicleucel) and ciltacabtagene autoleucel (cilta-cel) represent low long-term value at their current pricing levels, according to the Institute for Clinical and Economic Review (ICER) in a final evidence report released May 11.
While last week’s marathon Oncologic Drugs Advisory Committee meeting to consider accelerated approvals for cancer drugs that didn’t demonstrate effectiveness in confirmatory trials was a good step forward, oncologists need the FDA to do more to ensure drug labeling truly reflects the benefit of the product.
The FDA’s Oncologic Drugs Advisory Committee voted 6-2 April 29 to recommend withdrawing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) as a third-line treatment for a subgroup of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer. The vote was based on FDA assurances that, if it withdrew the approval, it would work with Merck to delay the withdrawal or set up an access program to ensure the estimated 1,000 patients who are beyond first-line treatment could still get Keytruda.
