AbbVie Announces FDA’s Acceptance of sNDA for PR for Imbruvica (ibrutinib) + Gazyva (Obinutuzumab)

 AbbVie Announces FDA’s Acceptance of sNDA for PR for Imbruvica (ibrutinib) + Gazyva (Obinutuzumab)

Shots:

  • The sNDA application is based on results of P-III iLLUMINATE (PCYC-1130) trial assessing Imbruvica (420) + Obinutuzumab (1000) vs chlorambucil (Days 1 & 15) + obinutuzumab (1000) over 6 cycles in patients with 1L CLL/SLL
  • The iLLUMINATE study demonstrated 1EP as PFS, which showed longer PFS rate for Imbruvica + Obinutuzumab vs chlorambucil + obinutuzumab, as per IRC
  • Imbruvica is novel PO BTKi qd therapy and has received nine FDA approvals across six diseases. The combination with anti-CD20 will be a novel CT-free combination if approved by the FDA for 1L CLL treatment

Click here to read full press release/ article | Ref: AbbVie | Image: Reeves Recruiting

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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