FDA Approvals, News & Updates

Recently, officials with the FDA granted orphan drug designation (ODD) to alemtuzumab (CLLS52; Cellectis), which is an investigational product used as part of the lymphodepletion regimen administered before UCART22, evaluated in the BALLI-01 clinical trial in relapsed/refractory B-cell acute lymphoblastic leukemia.

Shield, Guardant Health has been FDA approved and is now covered by Medicare as the first blood test for primary colorectal cancer (CRC) screening

On June 26, 2024, the FDA approved epcoritamab-bysp (Epkinly; Abbvie and Genmab) as the first and only T-cell engaging bispecific antibody administered subcutaneously for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after ≥2 lines of prior therapy.

FDA officials approved pembrolizumab (Keytruda, Merck) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma efficacy of this treatment was evaluated in KEYNOTE-868/NRG-GY018.

On November 8, 2023, the FDA approved fruquintinib (Fruzaqla; Takeda Pharmaceuticals), an inhibitor of VEGFR-1, -2, and -3, for the treatment of metastatic colorectal cancer (mCRC) in adults who received previous fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. The FDA granted fruquintinib priority review for this indication.

On October 27, 2023, the FDA approved toripalimab-tpzi (Loqtorzi; Coherus BioSciences), a PD-1 monoclonal antibody, in combination with cisplatin and gemcitabine chemotherapy, for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma, and as a single agent for adults with recurrent, unresectable, or metastatic nasopharyngeal carcinoma that progressed during or after treatment with a platinum-containing chemotherapy.

On November 16, 2023, the FDA approved the use of pembrolizumab (Keytruda; Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

On October 24, 2023, the FDA approved ivosidenib (Tibsovo; Servier Pharmaceuticals), an oral tyrosine kinase inhibitor, for the treatment of relapsed or refractory myelodysplastic syndromes (MDS) in adults with a susceptible IDH1 mutation, as detected by an FDA-approved test.

On October 13, 2023, the FDA approved a new indication for nivolumab (Opdivo; Bristol-Myers Squibb), a PD-1 inhibitor, for the adjuvant treatment of completely resected stage IIB/C melanoma in patients aged ≥12 years. The FDA granted this application an orphan drug designation.

On October 11, 2023, the FDA approved a new indication for encorafenib (Braftovi; Array BioPharma) combined with binimetinib (Mektovi; Array BioPharma) for adults with metastatic non–small cell lung cancer (NSCLC) and a BRAF^V600E mutation, as detected by an FDA-approved test.