AbbVie Receives Positive CHMP Opinion for VENCLYXTO® (venetoclax) as a Combination Regimen for Adult Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive C...
AbbVie Inc. (ABBV)
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Source: PR Newswire
NORTH CHICAGO, Ill., April 23, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for VENCLYXTO® (venetoclax) in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which is expected to deliver its final decision on VENCLYXTO combination therapy for use in AML in the first half of 2021.The positive CHMP opinion represents the third for an extension of indications for VENCLYXTO. The opinion is based on results from the double-blind, placebo-controlled VIALE-A (M15-656) and the Phase 1b open-label, nonrandomized, multicenter M14-358 trial. "This positive CHMP opinion for VENCLYXTO in acute myeloid leukemia is a critical
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ABBV
Earnings
- 4/26/24 - Miss
ABBV
Sec Filings
- 4/26/24 - Form 8-K
- 4/3/24 - Form 8-K
- 4/2/24 - Form 4
- ABBV's page on the SEC website