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Janssen Highlights Commitment to Advancing Transformative Innovations in Oncology with Scientific Updates from Deep, Diverse Pipeline and Portfolio at ASCO and EHA Virtual Scientific Programs

/PRNewswire/ The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 30 company-sponsored studies, including six oral. ....

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FDA approves Janssen's Rybrevant

FDA approves Janssen's Rybrevant
pharmatimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmatimes.com Daily Mail and Mail on Sunday newspapers.

Jill Feldman , Janssen Rybrevant , Peter Lebowitz , Drug Administration , Janssen Research Development , Janssen Research , Phasei Chrysalis , ஜில் ஃபெல்ட்மந் , பீட்டர் லெபோவிட்ஸ் , ஜான்சன் ஆராய்ச்சி வளர்ச்சி , ஜான்சன் ஆராய்ச்சி ,

RYBREVANT™ (amivantamab-vmjw) Receives FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

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HORSHAM, Pa., May 21, 2021 /PRNewswire/ The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has granted the accelerated approval of RYBREVANT
TM (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
1 RYBREVANT
TM is the first fully-human, bispecific antibody approved for the treatment of patients with NSCLC that targets EGFR exon 20 insertion mutations, which are the third most prevalent activating EGFR mutation. ....

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Janssen seeks EU approval for first CAR-T therapy cilta-cel

Janssen seeks EU approval for first CAR-T therapy cilta-cel
4th May 2021
Johnson & Johnson’s (J&J) pharma division Janssen has filed its first CAR-T cell therapy ciltacabtagene autoleucel (cilta-cel) with the European Medicines Agency (EMA), seeking approval for the treatment of patients with relapsed/refractory multiple myeloma.
The marketing authorisation application (MAA) is supported by results from Janssen’s ongoing Phase Ib/II CARTITUDE-1 study, which is investigating the safety and efficacy of cilta-cel.
Results from this study were recently presented at the virtual American Society of Hematology (ASH) annual meeting, showing ‘very high’ overall response rates (ORR).
In the results, 97% of patients achieved a response, with 67% achieving a stringent complete response (sCR) at a median follow-up of 12.4 months. ....

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Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma

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Application based on positive Phase 1b/2 data from the CARTITUDE-1 study and follows confirmation of accelerated assessment by the Committee for Medicinal Products for Human Use of the European Medicines Agency
The Janssen Pharmaceutical Companies of Johnson Johnson announced today that they have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel, an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma.
The application is supported by positive results from the ongoing Phase 1b/2 CARTITUDE-1 study, investigating the safety and efficacy of cilta-cel. ....

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