Bristol Myers Squibb’s Cobenfy failed to outdistance a placebo in a Phase 3 test that evaluated the drug as an adjunct to antipsychotics in schizophrenia patients. Last September, the FDA approved Cobenfy as a standalone schizophrenia treatment.
The combination of Bristol Myers Squibb cancer drugs Opdivo and Yervoy landed FDA approvals for the first-line treatment of colorectal cancer and hepatocellular carcinoma. Several other products also expanded their approved uses in our recap of recent regulatory news.
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Multiple myeloma cell therapy Abecma is the lone remaining asset of 2seventy Bio, which spun out from Bluebird Bio in 2021. 2seventy and Bristol Myers Squibb currently share in U.S. commercialization of Abecma.
Bristol Myers Squibb’s Opdualag paired with blockbuster immunotherapy Opdivo failed a clinical trial testing the regimen as an adjuvant therapy for patients whose melanoma has been surgically removed. While Opdualag is still projected to reach blockbuster status, it could face competition from a Regeneron Pharmaceuticals drug.
Opdivo Qvantig, administered by injection in less than five minutes, is now FDA approved for most solid tumor indications covered by Opdivo, a 30-minute intravenous infusion. The new product will help Bristol Myers Squibb compete with biosimilars as Opdivo faces looming patent expiration.
Sotyktu, which became the first TYK2 inhibitor to reach the market after its 2022 FDA approval in plaque psoriasis, now has positive data from two pivotal tests in psoriatic arthritis. Bristol Myers Squibb is trying to add new indications for the drug and stay ahead of competitors including Takeda Pharmaceutical.
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Bristol Myers Squibb is turning to the prime-editing technology of Prime Medicines for the R&D of new cell therapies for cancer and immunology. The pharma giant is paying $110 million up front to begin the collaboration.
Bristol Myers Squibb’s Cobenfy treats schizophrenia by going after a different target than currently available antipsychotic drugs, which is intended to offer better efficacy and safety. The drug came from the pharma giant’s $14 billion acquisition of Karuna Therapeutics.
Bristol Myers Squibb drug Augtyro now has a tumor-agnostic approval permitting the drug to be used to treat all solid tumors positive for NTRK gene fusions. Augtyro came from BMS’s $4.1 billion acquisition of Turning Point Therapeutics.
The CAR T-therapies Abecma and Carvykti may now be used in earlier lines of treatment for multiple myeloma. The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products.
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Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.
By acquiring RayzeBio, Bristol Myers Squibb gains a pipeline of radiopharmaceuticals and the infrastructure for manufacturing these targeted cancer therapies. In the second half of 2023 alone, BMS has committed about $24 billion to business development deals.
Bristol Myers Squibb is expanding its scope in cancer by acquiring rights to a Phase 1-ready Orum Therapeutics program that brings a new twist to antibody drug conjugates. The deal is the latest business development move in the hot field of ADCs.
Acquiring Mirati Therapeutics brings Bristol Myers Squibb Krazati, one of two FDA-approved therapies addressing a KRAS cancer mutation. The deal comes as BMS looks to add revenue-generating products as patent expirations loom for several of its cancer products.
Bristol Myers Squibb drug Reblozyl is now approved as a first-line therapy for anemia caused by myelodysplastic syndromes, a group of blood cancers. It’s the third indication for the drug, which analysts project could top $4 billion in peak sales.