Genentech’s Venclexta Receives New FDA Approval

Genetech, which is part of the Roche Group (OTCQX:RHHBY;SIX:ROG), received a quick approval for its drug Venclexta.

As per Wednesday’s (November 21) announcement, the US Food and Drug Administration (FDA) gave Venclexta accelerated approval for newly diagnosed acute myeloid leukemia (AML) patients. Genentech submitted the supplemental new drug application for this indication in July.

The drug must be coupled with a hypomethylating agent, or low-dose cytarabine. The treatment is for patients aged 75 years and up who aren’t able to take the current intensive induction chemotherapy from coexisting medical conditions.

Abbvie (NYSE:ABBV) is co-developing the drug, meaning this approval is a win for both companies. Abbvie is responsible for commercialization outside of the US, whereas both companies are working to develop the drug in the US.

The accelerated approval program allows the conditional approval for therapies that serve patients with a serious unmet condition. To continue with this approval, additional confirmatory trials will be reviewed.

The drug had also previously received priority review for its indication, which had shown the potential an a significant improvement over other treatments.

Dr. Sandra Horning, chief medical officer and head of global product development at Genentech, said AML is one of the most aggressive and difficult to treat blood cancers.

“Many people with acute myeloid leukemia are unable to tolerate standard intensive chemotherapy,” Horning said, and added Venclexta is giving those patients a new option.

AML is most common leukemia in adults and has the lowest survival rate for every type of leukemia. The press release estimates there will be 20,000 new AML cases in the US this year. Many of patients over 60 aren’t able to tolerate the noted chemotherapy.

The drug is also approved for chronic lymphocytic leukemia, and small lymphocytic lymphoma, for patients that have received at least one other treatment for the indications. Both are cancers that affect white blood cells.

This approval was based off multiple studies to treat the drug in newly-diagnosed AML patients. In the M14-358 study, the complete remission (CR) rate was 37 percent and 24 percent for patients with partial blood count recovery (CRh). Patients who took both Venclexta plus decitabine had a 54 percent CR rate and an 8 percent CRh rate.

Common side effects found from these therapy regimes were low white blood cell count with fever, pneumonia, device-related infection and more.

Genentech is a global biotechnology company which merged with Roche in 2009. In multiple indications such as infectious diseases, ophthalmology, neuroscience and more, Genentech currently has 47 molecules its developing.

Abbvie is another Big Pharma which originated from Abbott (NYSE:ABT) in 2013. Abbvie has proven to become a strong competitor with currently blockbuster drugs such as Humira, Imbruvica and of course, Venlexta.

Investor takeaway

Roche’s share price on the OTC increased under one percent to US$31.02 over the trading period on Thursday (November 22).

Abbvie’s stock price made a 2.27 percent decreased to US$86.15, over the same period.

According to TipRanks, neither company reports from analysts released from this approval. Based on other analyst ratings, Roche’s share price could elevate to US$34 over the next six months, and Abbvie’s to US$135 over the same time period.

Genetech and Abbvie’s robust pipelines serves as a spectrum of opportunities for investors to engage in. These global likely won’t be without exciting news in the future.

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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.