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Roche, AbbVie Get FDA Approval for Venclexta Label Expansion

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Roche (RHHBY - Free Report) and partner AbbVie, Inc. (ABBV - Free Report) announced that the FDA has granted accelerated approval for a label expansion of Venclexta (venetoclax).

The FDA granted accelerated approval to Venclexta in combination with a hypomethylating agent (azacitidine or decitabine) or low-dose cytarabine (LDAC) for the treatment of patients suffering from newly-diagnosed acute myeloid leukaemia (AML) who are aged 75 years or older or those ineligible for intensive induction chemotherapy due to coexisting medical conditions.

The approval was based on positive results from the M14-358 and the M14-387 studies, which showed durable remissions in patients suffering from newly-diagnosed AML.

Consequently, Venclexta now is indicated for all AML patients regardless of subtypes.

The FDA generally grants accelerated approval to a drug that fills an unmet medical need for a serious condition. Continued approval for this indication may be contingent upon verification and description of clinical benefit observed in confirmatory trials.

Earlier, the FDA had granted Priority Review to the supplemental New Drug Application (sNDA) for Venclexta. The FDA had earlier granted two Breakthrough Therapy designations to Venclexta for the treatment of patients with previously untreated AML who are ineligible for intensive chemotherapy, either in combination with a hypomethylating agent or LDAC, based on results from the two studies. 

In June 2018, the FDA granted regular approval to Venclexta for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

The label expansion of the drug will expand the patient population, which, in turn, should boost sales.

While Roche and AbbVie commercialize the drug in the United States, the latter is responsible for the same outside the United States.

Shares of Roche have gained 1.3% so far this year compared with the industry’s growth of 10.8%.


Roche is a leader in oncology market with a diverse portfolio. Approval of new drugs and potential label expansion of existing drugs bode well for Roche, as its legacy drugs like Avastin, Herceptin and MabThera are facing competition from biosimilars. Novartis (NVS - Free Report) has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen (AMGN - Free Report) too has got its biosimilar of Avastin.

Zacks Rank

Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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