FDA Approvals, News & Updates
On March 21, 2022, the FDA approved a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck) as monotherapy for advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR), as determined by an FDA-approved test, in patients whose disease progressed after systemic therapy in any setting and who are not candidates for curative surgery or radiation therapy. Read More ›
On March 11, 2022, the FDA accelerated the approval of the oral PARP inhibitor olaparib (Lynparza; AstraZeneca) for the adjuvant treatment of adults with HER2-negative, high-risk early breast cancer and deleterious or suspected deleterious germline BRCA mutation after neoadjuvant or adjuvant chemotherapy. Read More ›
On January 25, 2022, the FDA accelerated the approval of tebentafusp-tebn (Kimmtrak; Immunocore), a bispecific gp100 peptide-HLA–directed CD3 T-cell engager, for the treatment of adults with HLA-A*02:01 unresectable or metastatic uveal (intraocular) melanoma. The FDA granted tebentafusp breakthrough therapy and orphan drug designations for this indication. Read More ›
On December 15, 2021, the FDA approved a new indication for abatacept (Orencia; Bristol Myers Squibb), a selective T-cell co-stimulation modulator, in combination with a calcineurin inhibitor and methotrexate, for the prophylaxis of acute graft-versus-host disease (GVHD) in adults and pediatric patients aged ≥2 years receiving hematopoietic stem-cell transplantation from a matched or 1 allele-mismatched unrelated donor. The FDA granted abatacept a priority review and breakthrough therapy and orphan drug designations. Read More ›
On December 3, 2021, the FDA approved a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck) for the adjuvant treatment of adult and pediatric patients (age ≥12 years) with stage IIB or IIC melanoma following complete resection. Read More ›
On November 30, 2021, the FDA approved the combination of subcutaneous daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Biotech) plus carfilzomib (Kyprolis; Amgen) and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received 1 to 3 previous lines of therapy. Read More ›
On November 29, 2021, the FDA accelerated the approval of pafolacianine (Cytalux; On Target Laboratories), a novel fluorescent imaging agent, for adults with ovarian cancer as an adjunct for identifying inoperable malignant lesions. Read More ›
On September 22, 2021, the FDA approved a new indication for ruxolitinib (Jakafi; Incyte) for the treatment of patients aged ≥12 years with chronic graft-versus-host disease (GVHD) after 1 or 2 lines of systemic therapy. Ruxolitinib received an orphan drug designation for this indication. Read More ›
On October 12, 2021, the FDA approved a new indication for the cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio; Eli Lilly), in combination with tamoxifen or an aromatase inhibitor as initial endocrine-based therapy, for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, node-positive, early breast cancer at high risk for recurrence, and a Ki-67 score ≥20%, as determined by an FDA-approved test. Read More ›
On October 13, 2021, the FDA approved a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck) for use in combination with chemotherapy, with or without bevacizumab (Avastin; Genentech), for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score ≥1) as determined by an FDA-approved test. Read More ›