Bristol Myers Squibb Company and 2seventy Bio, Inc. stand to expand the addressable market for the BCMA-directed CAR-T cell therapy Abecma (idecabtagene vicleucel) now that the US Food and Drug Administration has approved it for third-line and later multiple myeloma.
BMS’s Abecma Shakes Up Myeloma With Earlier-Line Approval From FDA
The US FDA approved Abecma for multiple myeloma after two prior lines of therapy, while the agency was also expected to imminently decide on earlier-line approval for J&J/Legend’s Carvykti.
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The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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The German group is paying $3.9bn to get hold of the US firm and its two approved products.
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Akeso’s penpulimab will be the second to hit the US market for nasopharyngeal carcinoma, but the first to win FDA approval for the indication based on clinical findings in US patients.
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Genmab will submit an sBLA for Epkinly in R/R follicular lymphoma in H1 2025, backed by positive Phase III data.
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Drugmakers aren’t expecting a big financial hit from tariffs for now, but a report commissioned by PhRMA suggests the cost of pharma-sector tariffs could be steep.
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Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.