FDA News

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.

The FDA set the Under the Prescription Drug User Fee Act date for June 24, 2022.

Tebentafusp is now the first FDA-approved therapy to treat unresectable or metastatic uveal melanoma.

Pembrolizumab has been approved for the adjuvant treatment of adults and pediatric patients with stage IIB or IIC melanoma who have underwent complete resection.

The FDA approval of sirolimus protein-bound particles marks the first approved therapeutic option for patients with advanced PEComa.

Pembrolizumab represents the first immunotherapy approved to treat patients with renal cell carcinoma in the adjuvant setting.

Ropeginterferon alfa-2b-njft is now an FDA-approved drug for the treatment of polycythemia vera.

The new Cilta-Cel PDUFA decision date is February 28, 2022.

Parsaclisib has been granted a priority review for 3 indications that include relapsed or refractory follicular, marginal zone, and mantle cell lymphoma.

The FDA have granted an accelerated approval to acimibinib, which treats CML by binding to the ABL myristoyl pocket.

Atezolizumab is the first immunotherapy approved in the adjuvant setting to treat NSCLC.

Pembrolizumab is approved both in combination with chemotherapy, with or without bevacizumab, and as a single agent for the treatment of patients with recurrent or metastatic cervical cancer.

Abemaciclib is the first and only FDA approved CDK4/6 inhibitor to treat HR-positive, HER2-negative high-risk early breast cancer.

Brexucabtagene autoleucel is now an FDA approved treatment options for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

Cetuximab represents the first approved anti-EGFR antibody which, in combination with encorafenib, is now available to treat adults with pretreated metastatic CRC with a BRAF V600E mutation.

The FDA has green lit mobocertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with an EGFR exon 20 insertion mutation.

Zanubrutinib received an accelerated approval for the indication of adults with marginal zone lymphoma with at least 1 prior treatment with an anti-CD20-based therapy.

Zanubrutinib (Brukinsa) is now FDA approved for the treatment of adults with Waldenström Macroglobulinemia.

Pembrolizumab has been granted full approval as a first-line treatment for a select population of patients with bladder cancer.

The Food and Drug Administration approved adjuvant nivolumab to treat urothelial carcinoma in patients who are at high risk of recurrence after undergoing radical resection, irrespective of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.