Category: BCMA Targeted Therapies

  • CHMP backs J&J’s myeloma CAR-T therapy Carvykti

    Johnson & Johnson is in course for approval of its multiple myeloma CAR-T therapy Carvykti in the EU the next few weeks, after getting a green light from the EMA’s human medicines committee. The CHMP recommended conditional approval for Carvykti (ciltacabtagene autoleucel or cilta-cel) as a treatment for adults with relapsed and refractory multiple myeloma […]

  • J&J goes after another FDA approval for a cancer bispecific

    Johnson & Johnson’s much-touted crop of bispecific antibodies for cancer generated its first commercial product in May, and the drugmaker has now filed for FDA approval of a second candidate. The latest to reach the regulatory stage is teclistamab, one of two bispecifics for multiple myeloma in the late-stage pipeline of J&J’s Janssen division stemming […]

  • FDA sets November review date for J&J’s multiple myeloma CAR-T cilta-cel

    Johnson & Johnson has secured a six-month FDA review for its multiple myeloma CAR-T therapy ciltacabtagene autoleucel (cilta-cel), narrowing the lead for Bristol-Myers Squibb and bluebird bio’s rival Abecma. The US regulator is now scheduled to complete its review of cilta-cel by 29 November for adults with relapsed and/or refractory multiple myeloma who have previously […]

  • Janssen files its first CAR-T therapy cilta-cel in Europe

    Johnson & Johnson’s Janssen unit has filed for approval of its multiple myeloma CAR-T ciltacabtagene autoleucel in Europe, chasing after a rival therapy from Bristol-Myers Squibb.  The BCMA-targeting CAR-T – also known as cilta-cel – has been filed with the EMA as a treatment for adults with relapsed/refractory multiple myeloma, an incurable form of blood […]

  • BCMA Targeted Therapies Summit

    Built with thought leaders from Seattle Genetics, Precision Biosciences and Kite Pharma, the inaugural industry-focused BCMA Targeted Therapies Summit will share the field’s cutting-edge and aggressive scientific advances of BCMA therapies within multiple myeloma. This summit is the first of its kind, uniting thought leaders in BCMA therapeutics drug development to discuss their challenges and […]