FDA Approvals, News & Updates

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 ›

FDA officials have granted accelerated approval to zongertinib (Hernexeos), a kinase inhibitor, for adults with unresectable or metastatic nonsquamous non–small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD)-activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. Read More ›

Both single-agent retifanlimab-dlwr (Zynyz; Incyte) and use with carboplatin and paclitaxel have been greenlit for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal. Read More ›