Johnson & Johnson’s (NYSE:JNJ)
The European Commission has approved Johnson & Johnson’s (NYSE:JNJ) bispecific antibody, Tecvayli (teclistamab), for monotherapy in treating patients with relapsed or refractory multiple myeloma.
Patients with disease progression on their most recent treatment regimen and who have undergone at least three prior therapies (an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody) are eligible for conditional approval. This is the first time Tecvayli has been approved in the world.
The European Commission (EC) will approve a marketing authorization application (MAA) for medicine in the case of an illness for which there is a tremendous unmet need despite a lack of the extensive data it would typically require. The potential advantages of these medicines should outweigh their potential disadvantages, and the applicant will be expected to supply extensive clinical evidence.
Data from the phase I/II MajesTEC-1 research, which demonstrated that therapy with teclistamab resulted in profound and long-lasting responses, formed the basis for the approval of Tecvayli. The overall response rate (ORR) was 63%, with 39.4% of patients obtaining a complete response (CR) or better after treatment with a weekly subcutaneous injection of teclistamab after a median of five prior lines of therapy. Progression-free survival was measured at 11.3 months, whereas total survival was measured at 18.3 months on average.
J&J’s stock price is down 3.3% this year, while the S&P 500 is down 0.9%.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive judgment on Tecvayli last month, suggesting that it be granted CMA, which led to its approval across Europe. In the US, Tecvayli is undergoing evaluation.
In a separate announcement, Johnson & Johnson’s (NYSE:JNJ) said it had appointed Larry Merlo as the non-executive chair of the board of the new Consumer Health company that will be created upon J&J’s dissolution. Johnson & Johnson has decided to spin off its Consumer Health business into a new public company to focus on its core competencies of pharmaceuticals and medical devices. The split is scheduled to take place in 2023.
Former CVS Health Corporation (CVS Quick QuoteCVS – Free Report) president and CEO Merlo. Merlo’s extensive knowledge of health and consumer trends, honed during his time at CVS Health, will be an asset to the new Consumer Health organization. From 2011 until 2021, Merlo was the president and chief executive officer of CVS Health.
Johnson & Johnson’s (NYSE:JNJ) had previously announced Thibaut Mongon’s appointment as CEO-designate back in May.
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Author Shariq Khan 
