Articles

On December 27, 2019, the FDA accelerated the approval of a new indication for olaparib (Lynparza; AstraZeneca) for the maintenance treatment of adults with metastatic pancreatic adenocarcinoma associated with a deleterious or suspected deleterious germline BRCA mutation, as detected by an FDA-approved test, and whose disease did not progress during ≥16 weeks of a first-line platinum-based chemotherapy regimen. Olaparib has been previously approved for ovarian cancer and for breast cancer associated with BRAF mutation.

On January 8, 2020, the FDA accelerated the approval of a new indi­cation for pembrolizumab (Keytruda; Merck & Co) for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer and carcinoma in situ, with or without papillary tumors, in patients who are ineligible for or who have elected not to undergo cystectomy. Pembrolizumab has been previously approved for many indications.

On December 23, 2019, the FDA accelerated the approval of fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo), a HER2-directed antibody and topoisomerase inhibitor conjugate, for the treatment of adults with unresectable or metastatic HER2-positive breast cancer after ≥2 previous anti-HER2–based regimens in the metastatic setting. The FDA granted fam-trastuzumab deruxtecan-nxki a breakthrough therapy designation.

On January 9, 2020, the FDA accelerated the approval of avapritinib (Ayvakit; Blueprint Medicines Corporation), a kinase inhibitor, for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes GIST that harbors a PDGFRA D842V mutation, which is the most common exon 18 mutation. The FDA granted breakthrough therapy and orphan drug designations to avapritinib.

On January 23, 2020, the FDA accelerated the approval of tazemetostat (Tazverik; Epizyme Inc), an EZH2 methyltransferase blocker, for the treatment of patients aged ≥16 years with metastatic or locally advanced epithelioid sarcoma (a subtype of soft-tissue sarcoma) that is not eligible for complete resection. Tazemetostat received an orphan drug designation for this indication.

Orlando, FL—The impact of poverty and low socioeconomic status on health and survival among children may be even more debilitating than suspected, according to new data presented at ASH 2019. Even in clinical trials, which are designed to provide consistent treatment across groups, socio­economic status was associated with “substantial” differences in survival, researchers were surprised to find out.

Orlando, FL—Mosunetuzumab is an investigational bi-specific T-cell engager (BiTE) agent dually targeting 2 proteins on the surface of lymphoma cells—CD3 (on the surface of T-cells) and CD20 (on the surface of B-cells).

On December 18, 2019, the FDA accelerated the approval of enfortumab vedotin-ejfv (Padcev; Astellas Pharma), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for the treatment of adults with locally advanced or metastatic urothelial cancer after immunotherapy with a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy. These are the current standard treatments for patients with bladder cancer, the sixth most common cancer in the United States. Urothelial cancer accounts for >90% of bladder cancers.

Orlando, FL—Tazemetostat (Tazverik), a first-in-class, oral, selective EZH2 inhibitor, has demonstrated single-agent antitumor activity in patients with relapsed or refractory follicular lymphoma, according to results of a phase 2 clinical trial presented at ASH 2019.