FDA News

The FDA has granted an accelerated approval to elacestrant (Orserdu) for the treatment of patients with estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer following at least 1 prior lines of endocrine therapy.

Pirtobrutinib has been approved for patients with mantle cell lymphoma. The prescribing label comes with warnings for infections, hemorrhage, cytopenias, atrial fibrillation and flutter, second primary malignancies, and embryo-fetal toxicity.

Pembrolizumab has been approved by the FDA as an adjuvant treatment for patients with stage IB, II, or IIIA following resection and platinum-based chemotherapy.

The FDA has approved zanubrutinib for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The prescribing label comes with warnings for hemorrhage, infections, cytopenias, second primary malignancies, and cardiac arrythmias.

The FDA has granted accelerated approval to tucatinib and trastuzumab for RAS wild-type, HER2-positive metastatic colorectal cancer. The prescribing information includes warnings for diarrhea and hepatotoxicity.

Mosunetuzumab is now an FDA approved treatment for patients with relapsed or refractory follicular lymphoma who have already undergone 2 or more lines or systemic therapy.

The FDA has approved updated labeling for capecitabine under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs.

Atezolizumab has been granted FDA approval for patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma.

Adagrasib has received accelerated approval for KRAS G12C mutated non–small cell lung cancer. The prescribing label comes with warnings for gastrointestinal toxicities, QTC interval prolongation, hepatotoxicity, and interstitial lung disease.

The FDA has approved brentuximab vedotin (Adcetris) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients with classical Hodgkin lymphoma.

Cemiplimab, in combination with platinum-based chemotherapy, has been approved for patients with advanced non–small cell lung cancer with no EGFR, ALK, or ROS1 aberrations.

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.

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 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.