FDA News

The FDA has approved eflapegrastim to treat febrile neutropenia. The agent should be administered 24 hours following cytotoxic chemotherapy. It comes with warnings for fatal splenic rupture, acute respiratory distress syndrome, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, and myelodysplastic syndrome.

Pegfilgrastim-fpgk, a biosimilar medicine of pegfilgrastim, has received FDA approval for patients with non-myeloid malignancies and a clinically significant incidence of febrile neutropenia.

The FDA has approved durvalumab for patients with advanced or metastatic biliary tract cancers. The immunotherapy comes with warnings for immune-related adverse events and infusion reactions.

Pemigatinib has received FDA approval for relapsed or refractory myeloid/lymphoid neoplasms and FGFR1 rearrangement. Patients receiving pemigatinib will require monitoring for ocular toxicities and high phosphate levels.

The FDA has approved trastuzumab deruxtecan for patients with HER2-mutated non–small cell lung cancer after the DESTINY-Lung02 results demonstrated a 57% overall response rate with the agent. The drug comes with warning for interstitial lung disease, neutropenia, and left ventricular dysfunction.

The FDA has granted capmatinib regular approval for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have a mutation leading to MET exon 14 skipping. The drug comes with warning for pneumonitis, hepatotoxicity, and pancreatic toxicity.

A biologics license application for the IL-15 superagonist N-803 has been accepted and the agent will be reviewed for the treatment of patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer carcinoma in situ.

Patients with hormone-sensitive prostate cancer who received darolutamide in combination with docetaxel experienced superior overall survival and time-to-pain progression benefit.

The biologics license application for omidubicel has been granted priority review and will be assessed as a potential treatment for patients with blood cancer who require allogeneic hematopoietic stem cell transplant.

The FDA has approved the first targeted therapy for patients with HER2-low metastatic breast cancer.

Based on data from the DESTINY-Breast04 trial, the FDA has granted a priority review designation for the supplemental biologics license application for fam-trastuzumab deruxtecan-nxki.

Mosunetuzumab, a CD20 and CD3 T-cell engaging bispecific antibody, received a priority review designation from the FDA for the treatment of patients with relapsed/refractory follicular lymphoma following at least 2 prior systemic therapies.

Mirvetuximab soravtansine (IMGN853) has been granted priority review by the FDA for the treatment of patients with FRα-high, platinum-resistant ovarian cancer who have previously received between 1 and 3 systemic therapies.

The FDA has approved crizotinib as a therapeutic option for patients with unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumors.

The FDA has approved lisocabtagene maraleucel as a second-line treatment for patients with relapsed or refractory large B-cell lymphoma.

The FDA approval of dabrafenib plus trametinib for BRAF V600E–mutated unresectable or metastatic solid tumors highlights a potential need for routine BRAF testing in clinical practice, experts say.

Tisagenlecleucel received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy.

Ivosidenib plus azacitidine received FDA approval for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) harboring IDH1 mutations.

Azacitidine (Vidaza) is now FDA approved for pediatric patients with newly diagnosed myelomonocytic leukemia.

Fam-trastuzumab deruxtecan-nxki is now an FDA-approved regimen for the treatment of patients with unresectable or metastatic HER2-positive breast cancer.

Axicabtagene ciloleucel is now FDA-approved for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.

Lutetium-177-PSMA-617 is now FDA-approved for the treatment of patients with metastatic castration-resistant prostate cancer who have already received androgen receptor pathway inhibition and taxane-based chemotherapy.

The doublet regimen of relatlimab/nivolumab has been approved for adults with unresectable or metastatic melanoma.

Olaparib is now FDA approved for patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer and who have already undergone chemotherapy before or after surgery.

Nivolumab combined with chemotherapy is now approved in the resectable non–small cell lung cancer setting.

The FDA has approved pacritinib for patients with cytopenic myelofibrosis and severe thrombocytopenia.

Newly FDA-approved ciltacabtagene autoleucel was found to induce an objective response rate of 98% in patients with relapsed/refractory multiple myeloma.

Adagrasib is currently being considered for approval as a treatment option for previously treated patients with KRAS G12C-mutated non-small cell lung cancer.