FDA News

Cobimetinib is now an FDA-approved therapy for patients with histiocytic neoplasms.

Patients with multiple myeloma who have already undergone 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, may now receive treatment with teclistamab-cqyv (Tecvayli).

The combination of durvalumab and tremelimumab has been approved for patients with unresectable hepatocellular carcinoma. The combination comes with warnings for immune-related adverse events and infusion reactions.

Futibatinib is now approved to treat patients with previously treated unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma. The agent comes with warnings for ocular toxicities, and hyperphosphatemia and soft tissue mineralization.

The FDA has approved sodium thiosulfate to protect the hearing of pediatric patients who are at least 1 year old and are receiving cisplatin-based treatments.

On September 22 and 23, 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) convened for a hearing to assess the risk-benefit ratio of 3 agents.

Selpercatinib was approved by the FDA for RET fusion–positive non–small cell lung cancer and locally advanced or metastatic RET fusion–positive solid tumors.

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.

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 scheduled 3 sessions for the Oncologic Drugs Advisory Committee to review updates on the new drug application for poziotinib tablets and data for the continued approval of indications for melphalan flufenamide and duvelisib.

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.