New FDA Specialty Approvals

New FDA Specialty Approvals

January 1, 2021

✦ Dec. 14: The FDA approved a new dosing time for Roche Group unit Genentech USA, Inc.’s Ocrevus (ocrelizumab) to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, as well as primary progressive MS. Twice-yearly dosing via a shorter two-hour infusion is now available for people who have not experienced any serious infusion reactions. The initial dose is administered as two 300 mg two-and-a-half-hour infusions two weeks apart and then subsequent doses are 600 mg every six months. The agency initially approved the drug for subsequent infusions of three-and-a-half hours. The drug’s annual list price is $65,000, according to its website. Visit www.ocrevus.com.

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New FDA Specialty Approvals

December 1, 2020

✦ Nov. 9: The FDA expanded the label of Foundation Medicine, Inc.’s FoundationOne Liquid CDx to identify people with BRCA1, BRCA2 and/or ATM alterations in metastatic castration-resistant prostate cancer who may be appropriate for treatment with AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib). The agency initially approved the liquid biopsy test in August (RSP 9/20, p. 8); it’s now approved as a companion diagnostic for seven targeted therapies across four tumor types. The manufacturer says it is the only FDA-approved blood-based test that can analyze more than 300 genes. Visit https://bit.ly/3gINu3h.

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New FDA Specialty Approvals

November 1, 2020

✦ Oct. 7: The FDA expanded the label of BioMarin Pharmaceutical Inc.’s Palynziq (pegvaliase-pqpz) to increase the maximum allowable dose to 60 mg for the treatment of adults with phenylketonuria. The agency initially approved the drug with a maximum dose of 40 mg on May 24, 2018 (RSP 6/18, p. 8). The recommended initial dosing of the phenylalanine (Phe)-metabolizing enzyme is 2.5 mg subcutaneously once weekly for four weeks. Then dosage should be titrated in a stepwise manner over at least five weeks to achieve a dosage of 20 mg once daily. That can be increased to 40 mg once daily after 24 weeks in people who have not achieved blood Phe control. Dosing can be increased to 60 mg once daily in people who have been on the 40 mg dose for at least 16 weeks and not achieved blood Phe control. Website Drugs.com lists the price of one syringe for all three doses — 2.5 mg/0.5 mL, 10 mg/0.5 mL and 20 mg/mL — as $541.94. Visit www.palynziq.com.

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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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