FDA Approvals, News & Updates

On August 11, 2023, the FDA accelerated the approval of the fixed-dose combination of niraparib and abiraterone acetate (Akeega; Janssen Biotech), with prednisone, for the treatment of adults with deleterious or suspected deleterious BRCA-mutated, castration-resistant prostate cancer, as determined by an FDA-approved test. The FDA granted this approval priority review.
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On August 9, 2023, the FDA granted regular approval to pralsetinib (Gavreto; Genentech), a kinase inhibitor of wild-type RET and oncogenic RET fusions and mutations, for the treatment of adults with metastatic non–small cell lung cancer (NSCLC) and RET fusion–positive gene mutation, as detected by an FDA-approved test.
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On June 15, 2023, the FDA accelerated the approval of glofitamab-gxbm (Columvi; Genentech), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after ≥2 lines of systemic therapy.
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On May 19, 2023, the FDA accelerated the approval of epcoritamab-bysp (Epkinly; Genmab US), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma after ≥2 lines of systemic therapy.
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On August 2, 2023, the FDA approved a new indication for trifluridine and tipiracil (Lonsurf; Taiho Oncology), in combination with bevacizumab (Avastin), for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti–vascular endothelial growth factor biologic therapy; and if RAS wild-type, an anti–epidermal growth factor receptor therapy.
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On July 31, 2023, the FDA approved a new indication for dostarlimab-gxly (Jemperli; GlaxoSmithKline), a PD-1 inhibitor, in combination with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).
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On July 20, 2023, the FDA approved quizartinib (Vanflyta; Daiichi Sankyo) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy after consolidation chemotherapy, for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) that is FLT3-internal tandem duplication (ITD)–positive, as detected by an FDA-approved test.
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On June 20, 2023, the FDA approved a new indication for talazoparib (Talzenna; Pfizer), a poly (ADP-ribose) polymerase inhibitor, in combination with enzalutamide (Xtandi; Astellas) for homologous recombination repair (HRR) gene mutation–positive, metastatic castration-resistant prostate cancer. The FDA granted this application priority review.
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On July 19, 2023, an EF3 tornado touched down in Rocky Mount, NC, badly damaging a Pfizer drug manufacturing facility that is responsible for producing nearly 25% of Pfizer’s sterile injectable medicines used in US hospitals.
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On March 22, 2023, the FDA granted accelerated approval to retifanlimab-dlwr (Zynyz; Incyte Corporation), a programmed cell death 1–blocking antibody, for the treatment of adult patients with metastatic or recurrent locally advanced Merkel-cell carcinoma.
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