Roche Holdings AGRHHBY announced positive results from a pivotal phase III study, MURANO, evaluating Venclexta plus Rituxan compared to bendamustine plus Rituxan (BR) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL).
Results from the study showed that a fixed duration of treatment with Venclexta plus Rituxan significantly reduced the risk of disease progression or death by 83% compared with BR.
The results were presented at the 59th American Society of Hematology Annual Meeting.
The primary endpoint of the study is investigator-assessed progression-free survival.
We note that Roche is developing Venclexta in collaboration with AbbVie, Inc. ABBV . Both the companies are jointly commercializing in the United States. AbbVie is commercializing the drug outside the United States.
The companies expect to submit the data from MURANO study to the FDA. We remind investors that the FDA granted accelerated approval to Venclexta in April 2016 for the treatment of CLL with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.
The MURANO study is being conducted with the aim of converting the current accelerated approval of Venclexta to a full approval.
Meanwhile, Venclexta has been granted four breakthrough therapy designations by the FDA in combination with Rituxan for people with relapsed or refractory CLL, as a monotherapy for relapsed or refractory CLL with 17p deletion in combination with hypomethylating agents (azacitidine or decitabine) for untreated acute myeloid leukaemia (AML) ineligible for intensive chemotherapy and in combination with low-dose cytarabine for patients with untreated AML ineligible for intensive chemotherapy.
Roche's hematology portfolio has approved drugs including MabThera/Rituxan, Gazyva/Gazyvaro, Tecentriq and Venclexta as well as an encouraging pipeline comprising candidates like polatuzumab vedotin/RG7596 and a small-molecule antagonist of MDM2 (idasanutlin/RG7388).
The company also obtained FDA approval for Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors.
So far this year, shares of the company have moved up 9.2% compared with the industry 's gain of 20%.
Approval of new drugs and a potential label expansion of existing drugs bode well for Roche as its legacy drugs like Herceptin, MabThera are already facing competition from biosimilars.
Novartis AG NVS has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen AMGN has also obtained FDA approval for a biosimilar version of Avastin for treatment of five types of cancers including lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma and cervix cancer.
Roche currently carries a Zacks Rank #4 (Sell).
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