FDA Approvals, News & Updates

On November 19, 2025, the FDA granted accelerated approval to sevabertinib (Hyrnuo), a kinase inhibitor, for adults with locally advanced or metastatic non-squamous non–small cell lung cancer (NSCLC) with HER2 tyrosine kinase domain (TKD)-activating mutations, as identified by an FDA-approved test, who had received prior systemic therapy. Read More ›

On November 21, 2025, the FDA approved pembrolizumab (Keytruda), or pembrolizumab with berahyaluronidase alfa-pmph (Keytruda Qlex), in combination with enfortumab vedotin-ejfv (Padcev), as neoadjuvant therapy followed by adjuvant therapy after cystectomy for adults with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. Read More ›

On December 3, 2025, the FDA granted traditional approval to pirtobrutinib (Jaypirca) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously treated with a covalent BTK inhibitor. Read More ›

On November 6, 2025, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with high-risk smoldering multiple myeloma (SMM). Darzalex Faspro is only indicated for patients with high-risk SMM. It is not indicated for other risk categories. Read More ›

On October 23, 2025, the FDA approved belantamab mafodotin-blmf (Blenrep) in combination with bortezomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma. This approval applies to patients who have received at least 2 prior therapies, including a proteasome inhibitor and an intermodulary agent. Read More ›

On October 24, 2025, the FDA approved revumenib (Revuforj) for the treatment of adult and pediatric patients aged 1 years and older with relapsed or refractory acute myeloid leukemia (AML) characterized by a susceptible nucleophosmin 1 (NPM1) mutation with no satisfactory alternative treatment options. Read More ›

Officials with the FDA have granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway) for adults with locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. Read More ›

The FDA has granted accelerated approval to linvoseltamab-gcpt (Lynozyfic), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody. Read More ›

Sunvozertinib (Zegfrovy) has been greenlit by the FDA for adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Read More ›

On August 6, 2025, officials with the FDA granted accelerated approval to dordaviprone (Modeyso), a protease activator, for adult and pediatric patients aged ≥1 year with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Read More ›