New FDA Specialty Approvals

✦ Jan. 14: The FDA granted an additional indication to Pfizer Inc.’s Xalkori (crizotinib) to treat children at least 1 year old and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK)-positive. The agency initially approved the drug on Aug. 26, 2011 (RSP 9/11, p. 6). The tyrosine kinase inhibitor had breakthrough therapy designation for the newest indication. The recommended dosage of the capsule is 280 mg/m2 twice daily based on body surface area. Website Drugs.com lists the price of 60 200 mg capsules as more than $19,400. Visit www.xalkori.com.

✦ Jan. 15: The FDA gave accelerated approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with Velcade (bortezomib) from Takeda Pharmaceutical Company Limited subsidiary Millennium Pharmaceuticals, Inc., cyclophosphamide and dexamethasone for the treatment of adults with newly diagnosed light chain amyloidosis. The agency initially approved the drug, which is a subcutaneous formulation of Darzalex, on May 1, 2020 (RSP 5/20, p. 8). The recommended dose is 1,800 mg daratumumab and 30,000 units of hyaluronidase. Drugs.com lists the price of an 1,800 mg-30,000 units single-dose vial as more than $7,916. Visit www.darzalex.com.

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• Radar on Specialty Pharmacy