FDA Approvals, News & Updates

On January 29, 2020, Eli Lilly announced that the FDA granted priority review to their New Drug Application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion-positive non–small-cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer. The FDA is aiming to provide its decision on the approval of selpercatinib in the third quarter of 2020. Read Article ›

On January 23, 2020, the FDA granted accelerated approval to tazemetostat (Tazverik; Epizyme), a methyltransferase inhibitor, for the treatment of metastatic or locally advanced epithelioid sarcoma in adults and pediatric patients aged ≥16 years who are not eligible for complete resection. Read Article ›

The FDA approval of avapritinib marks the first time a drug has been approved specifically for patients with GIST harboring PDGFRA exon 18 mutations, which are involved in approximately 10% of GIST cases. Read Article ›

On December 3, 2019, the FDA approved atezolizumab (Tecentriq; Genentech), in combination with paclitaxel protein-bound (Abraxane) and carboplatin chemotherapy, for the first-line treatment of adults with metastatic nonsquamous non–small-cell lung cancer (NSCLC) that does not harbor EGFR or ALK genomic mutations. Read Article ›

On December 16, 2019, the FDA approved a new indication for enzalutamide (Xtandi; Pfizer, Astellas) for the treatment of patients with metastatic castration-sensitive prostate cancer. Enzalutamide was previously approved for the treatment of patients with nonmetastatic and metastatic castration-resistant prostate cancer. Read Article ›

On December 27, 2019, the FDA approved a new indication for olaparib (Lynparza; AstraZeneca), for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. The FDA also approved the BRACAnalysis CDx test (Myriad Genetics) as a companion diagnostic to select patients with pancreatic cancer who are candidates for treatment with olaparib based on the identification of deleterious or suspected deleterious germline mutations in BRCA1 or BRCA2 genes. Read Article ›

The FDA has confirmed another strong year regarding the approval of innovative new drugs and biosimilars, including several agents used in the treatment of patients with cancer. Read Article ›

On November 14, 2019, the FDA granted accelerated approval to zanubrutinib (Brukinsa; BeiGene) for the treatment of patients with mantle-cell lymphoma who have received ≥1 previous therapies. Read Article ›

On November 15, 2019, the FDA approved crizanlizumab (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged ≥16 years with sickle-cell disease. Read Article ›

On November 21, 2019, the FDA approved acalabrutinib (Cal­quence; AstraZeneca) as initial or subsequent therapy for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This is the second approval under Project Orbis, a collaboration between the FDA, the Australian Therapeutic Goods Administration, and Health Canada. Read Article ›

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