Noted

The FDA granted accelerated approval to adagrasib (Krazati; Mirati) to treat advanced KRAS^G12C-mutated non–small cell lung cancer that advances on or after platinum-based chemotherapy and an immune checkpoint inhibitor. Adagrasib is the second such drug to be approved in the United States; Amgen's sotorasib (Lumakras) was greenlighted in May 2021 for the same indication.

The FDA also granted accelerated approval to mosunetuzumab (Lunsumio; Genentech) to treat adults with certain follicular lymphomas (FL). A bispecific CD20-directed CD3 T-cell engager, mosunetuzumab was tested in an open-label, multicenter, multicohort study involving 90 patients with relapsed/refractory FL after at least two systemic drug regimens, including an anti-CD20 mAb and an alkylating agent. The overall response rate was 80%.

PDS Biotechnology reported that a PDS0101-based triple combination therapy yielded a median overall survival (OS) of 21 months in 29 patients with advanced human papillomavirus 16–positive cancers of the anus, cervix, head and neck, vagina, and vulva refractory to immune checkpoint inhibitors; the historical median OS in such patients is 3 to 4 months.

Researchers dismantled the belief that mantle cell lymphoma (MCL) should initially be treated with intensive chemoimmunotherapy and an autologous stem cell transplant (ASCT). Based on studies showing solid responses to ibrutinib (Imbruvica; Janssen/Pharmacyclics) in relapsed MCL and in older patients as a first-line therapy, researchers found that taking ibrutinib and skipping ASCT or having just the ASCT yielded similar failure-free survival after 3 years.

Clovis Oncology filed for bankruptcy and sold the rights to FAP-2286, a targeted radionuclide therapy and imaging agent that targets fibroblast activation protein, to Novartis for $50 million and up to $333.75 million more for achieving development milestones and $297 million for meeting sales milestones. Clovis currently holds the rights to the PARP inhibitor rucaparib (Rubraca) and three other targeted radionuclides.

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