New FDA Specialty Approvals

Dec. 3: The FDA expanded the label of Tecentriq (atezolizumab) in combination with Abraxane (paclitaxel protein-bound) and carboplatin for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. The agency initially approved Tecentriq from Genentech USA, Inc., a Roche unit, in May 2016 (RSP 6/16, p. 6); it has multiple oncologic indications. Dosing for the newest use is 1,200 mg delivered via intravenous infusion over 60 minutes every three weeks prior to chemotherapy. If the initial 60-minute infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. After four to six cycles of chemotherapy are completed, Tecentriq 840 mg is administered every two weeks, 1,200 mg every three weeks or 1,680 mg every four weeks. Website Drugs.com lists the price of an 840 mg/14 mL vial of Tecentriq as more than $6,500. For more information, visit www.tecentriq.com.

Dec. 4: The FDA expanded the indication for FoundationOne CDx for use as a companion diagnostic for Novartis AG’s Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated advanced breast cancer following progression on or after an endocrine-based regimen. The agency initially approved Piqray in May 2019 (RSP 6/19, p. 8). The Foundation Medicine, Inc. test is approved for use with 18 therapies. Visit https://bit.ly/2ORBOAs.

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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