New FDA Specialty Approvals

New FDA Specialty Approvals

October 1, 2020

✦ Sept. 16: The FDA expanded the use of Roche’s CINtec PLUS Cytology test to help clinicians determine which women who test positive for human papillomavirus (HPV) via cobas 6800/8800 Systems require further diagnostic procedures to prevent disease progression. The test can detect two biomarkers associated with HPV infections that are transforming and can, if left untreated, progress to cervical precancer or cancer. The FDA initially approved the test in March (RSP 4/20, p. 8). Visit https://bit.ly/32YFreW.

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New FDA Specialty Approvals

September 1, 2020

✦ Aug. 5: The FDA gave accelerated approval to GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf) for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunotherapy agent. The agency granted the first-in-class anti-B-cell maturation antigen (anti-BCMA)-directed antibody priority review, as well as orphan drug and breakthrough therapy designations. The review was via the Real-Time Oncology Review. Recommended dosing is 2.5 mg/kg as an intravenous infusion over approximately 30 minutes once every three weeks. The price per 100 mg single-dose vial is $8,277; based on a patient weight of 175 pounds, the monthly treatment cost would be $23,900. Visit www.blenrep.com.

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New FDA Specialty Approvals

August 1, 2020

✦ July 7: The FDA approved Astex Pharmaceuticals, Inc., Taiho Oncology, Inc. and Otsuka Pharmaceutical Co., Ltd.’s Inqovi (decitabine and cedazuridine) for the treatment of adults with intermediate and high-risk myelodysplastic syndromes. The agency gave the application priority review and orphan drug designation. Review of the application was done in collaboration with agency counterparts in Canada and Australia through Project Orbis (RSP 10/19, p. 12). Dosing is one tablet once daily on days one through five of each 28-day cycle. Taiho Oncology will commercialize the drug in the U.S. Its launch is pending. Visit www.inqovi.com.

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New FDA Specialty Approvals

July 1, 2020

✦ May 29: The FDA expanded the label of Eli Lilly and Co.’s Cyramza (ramucirumab) to include, in combination with erlotinib, the first-line treatment of people with metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 (L858R) mutations. Dosing is 10 mg/kg via intravenous infusion every two weeks with daily erlotinib. The monthly list price for this indication is $11,103. Visit www.cyramza.com.

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New FDA Specialty approvals

June 1, 2020

✦ May 6: The FDA gave accelerated approval to Novartis Pharmaceuticals Corp.’s Tabrecta (capmatinib) for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 skipping (METex14) as detected by an FDA-approved test. The agency also approved Foundation Medicine, Inc.’s FoundationOne CDx as a companion diagnostic for this use. The recommended dose for the tablet is 400 mg twice daily. The list price for a 28-day supply is $17,950. Visit www.us.tabrecta.com and https://bit.ly/2Sp4MJo.

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New FDA Specialty Approvals

May 1, 2020

✦ April 8: The FDA granted an additional approval to Pfizer Inc. subsidiary Array BioPharma Inc.’s Braftovi (encorafenib) in combination with Lilly USA, LLC’s Erbitux (cetuximab) for the treatment of adults with metastatic colorectal cancer with the BRAFV600E mutation, as detected by an FDA-approved test (see brief below), after prior therapy. The agency initially approved the capsule in June 2018 (RSP 7/18, p. 10). The recommended dose for the new use is 300 mg once daily in combination with Erbitux. Website GoodRx lists the price of two bottles, each with 90 75 mg capsules, as more than $12,400. Visit www.braftovi.com.

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