Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line
Johnson & Johnson (JNJ)
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Source: PR Newswire
Approval based on unprecedented Phase 3 data demonstrating statistically significant improvements in progression–free survival and overall survival versus standard of care regimens83.3% of patients were alive at three years, indicating durable clinical benefitHORSHAM, Pa., March 5, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced that the U.S. Food and Drug Administration (FDA) approved TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.1 TECVAYLI® and DARZALEX FASPRO® work synergistically to prime and activate the immune system to eradicate myeloma cells that express the BCMA protein.1 This approval offers a potential new standard of care (SOC) as early as second line and brings a novel
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- Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line [Yahoo! Finance]Yahoo! Finance
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JNJ
Earnings
- 1/21/26 - Beat
JNJ
Sec Filings
- 3/3/26 - Form 4
- 2/27/26 - Form 144
- 2/23/26 - Form 4
- JNJ's page on the SEC website