Oct. 25 Quick Takes: FDA approves J&J’s Tecvayli, first bispecific T cell engager for MM

FDA’s accelerated approval of Tecvayli teclistamab-cqyv from Johnson & Johnson (NYSE:JNJ) to treat patients with refractory multiple myeloma who have received at least four prior lines of therapy marks the agency’s first of a bispecific T cell engager to treat the disease. It’s Janssen’s fourth FDA-approved MM drug, and the first T cell engaging bispecific antibody to reach the European or U.S. markets since the 2016 approval of Blincyto blinatumomab from Amgen Inc. (NASDAQ:AMGN). The EC approved Tecvayli, which targets CD3 x BCMA, in August.

Novartis AG (SIX:NOVN; NYSE:NVS) revealed in its 3Q22 earnings report that it discontinued the development of iscalimab (CFZ533), which was in Phase II testing to prevent organ rejection in liver transplantation patients, due to its unfavorable benefit-risk profile compared with tacrolimus. It also ended the development of canakinumab as adjuvant treatment for non-small cell lung cancer and UNR844 for presbyopia, which it obtained by acquiring Encore Vision Inc. Novartis said it will not seek U.S. approval of PD-1 inhibitor tislelizumab to treat nasopharyngeal carcinoma; it plans to out-license icenticaftor (QBW251) for chronic obstructive pulmonary disease. The pharma is emphasizing “high-value” programs with potential peak sales of at least $2 billion...