New FDA Specialty Approvals

✦ July 9: The FDA gave an additional approval to Astellas Pharma US, Inc. and Seagen Inc.’s Padcev (enfortumab vedotin-ejfv) for the treatment of adults with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have received at least one line of therapy. The agency also converted the Nectin-4-directed antibody and microtubule inhibitor conjugate’s accelerated approval, granted Dec. 18, 2019, to regular approval for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before or after surgery or in a locally advanced or metastatic urothelial cancer setting. Dosing for both indications is 1.25 mg/kg via a 30-minute intravenous infusion on days one, eight and 15 of a 28-day cycle. Website Drugs.com lists the price of a 20 mg lyophilized powder as more than $2,380.00.

✦ July 12: The FDA granted another indication to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least one line of therapy, including lenalidomide and a proteasome inhibitor. The agency initially approved the anti-CD38 monoclonal antibody on May 1, 2020. The recommended dosage is 1,800 mg/30,000 units subcutaneously into the abdomen over approximately three to five minutes weekly for weeks one to eight, every two weeks from weeks nine to 24 and then every four weeks. Drugs.com lists the price of an 1,800 mg/30,000 per 15 mL vial as more than $8,290.

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