Roche (RHHBY), AbbVie's Leukemia Drug Venclexta Get Full FDA Nod

Roche RHHBY announced that the FDA has granted full approval to leukemia drug, Venclexta, in combination with Vidaza or Dacogen or low-dose cytarabine (LDAC).

The combination has been approved for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.

This approval converts Venclexta’s accelerated approval in this setting to full approval. The drug was previously granted provisional approval in this setting under the FDA’s accelerated approval program in November 2018.

Venclexta is being developed by Roche in collaboration with AbbVie ABBV. It is jointly commercialized by the companies in the United States and commercialized by AbbVie, under the brand name Venclyxto, outside of the United States.

The approval was primarily based on positive results from two phase III studies — VIALE-A and VIALE-C. Results of the VIALE-A study showed that Venclexta plus Vidaza significantly reduced the risk of death by 34% compared to Vidaza alone. Moreover, patients treated with Venclexta plus Vidaza had significantly higher rates of complete remission (CR) with 37% compared to 18% in patients treated with only Vidaza. The Venclexta plus Vidaza combination also led to higher rates of CR and CR with partial hematologic recovery. 

Results from the VIALE-C study showed that 27% of patients treated with Venclexta plus LDAC achieved a CR versus 7.4% of patients treated with LDAC alone. The median OS for people treated with Venclexta plus LDAC was 7.2 months versus 4.1 months for patients treated with LDAC alone.

Further, updated results from additional phase I/II studies of Venclexta in people with newly-diagnosed AML were included in the FDA submissions as supporting data.

The approval of the regimen will provide an advanced treatment option for older AML patients, including higher response rates, greater transfusion independence, longer durations of remission and ultimately significantly improved overall survival compared to Vidaza alone.

The approval will strengthen Roche’s hematology portfolio, which already comprises MabThera/Rituxan, Gazyva/Gazyvaro, Polivy and Hemlibra.  Among these, Rituxan is facing competition from biosimilars.

The company’s stock has gained 4.6% in the year so far against the industry’s decline of 1.1%.


Roche’s performance in the recently reported third-quarter results showed that sales somewhat stabilized after the decline in the second quarter due to the coronavirus outbreak. While growth in Ocrevus, Perjeta, Tecentriq and Hemlibra maintained momentum, COVID-19 disruptions and biosimilar competition weighed on the performance.

Nevertheless, demand for Roche’s diagnostic tests should maintain momentum as COVID-19 and emergency testing strongly increased in the first nine months of 2020.

Meanwhile, the company has entered into a partnership with Regeneron REGN for the latter’s new antiviral antibody cocktail for COVID-19.

Roche currently carries a Zacks Rank #3 (Hold).  A better-ranked large-cap pharma stock is Sanofi SNY, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Sanofi’s earnings estimates grew 2 cents for 2020 in the past thirty days and a cent for 2021.

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