New FDA Specialty Approvals

March 3: The FDA expanded the label for Pfizer Inc.’s Lorbrena (lorlatinib) to include the first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test (see brief below). The agency also converted the 2018 accelerated approval for ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor or those whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor for metastatic disease to full approval (RSP 11/18, p. 8). Recommended dosing for the tablet is 100 mg once daily. Website Drugs.com lists the price of 30 100 mg tablets as more than $18,480. Visit www.lorbrena.com.

March 4: The FDA approved an additional indication for Roche Group member Genentech USA, Inc.’s Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease. The agency initially approved the interleukin-6 inhibitor on Jan. 8, 2010 (RSP 1/10, p. 6). It gave the newest indication priority review. The recommended dose for the new use is 162 mg once every week as a subcutaneous injection. Drugs.com lists the price of one 162 mg/0.9 mL solution as more than $1,130. Visit www.actemra.com.

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