Quantcast

Roche's Avastin Gets Full FDA Approval for Brain Cancer


Shutterstock photo

Roche Holding AG's RHHBY member, Genentech announced that the FDA has converted accelerated approval for Avastin (received in May 2009) for previously treated glioblastoma, most aggressive form of brain cancer, to full approval.

The full approval was based on data from the phase III EORTC 26101study in which Avastin-based treatment increased the time to disease progression or death compared to chemotherapy alone. The study, however, did not meet the primary endpoint as there was no significant increase in overall survival with Avastin-based treatment.

However, it showed that patients were able to completely stop intake of corticosteroids while on treatment in the Avastin arm compared to the control arm. The evidence from the study, which showed that Avastin treatment delayed disease progression and reduced the need for corticosteroids, led to the conversion of the provisional approval to a full one.

Apart from the recent approval, the drug is already approved in the United States  for various indications that include- first- or second-line treatment of metastatic colorectal cancer, advanced nonsquamous non-small cell lung cancer (NSCLC), metastatic kidney cancer and advanced cervical cancer and recurrent ovarian cancer.

So far this year, shares of the company have increased 8.4% compared with the industry 's gain of 15%.

However, the drug has been facing competition and has been witnessing declining sales . In September 2017, Amgen AMGN and its partner Allergan AGN announced that the FDA approved their biosimilar version of Avastin for treatment of five types of cancers including lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma and cervix cancer. The biosimilar to be marketed by the trade name Mvasi is the first cancer biosimilar approved in the United States. It is also the first biosimilar for Avastin in the same country.

Zacks Rank & Stocks to Consider

Roche carries a Zacks Rank #4 (Sell). A top ranked health care stock in the same space is Johnson and Johnson JNJ sporting a Zacks Rank #2 (Buy). You can see  the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

Johnson and Johnson's earnings per share estimates have moved up from $7.18 to $7.28 for 2017 and from $7.72 to $7.85 for 2018, over the last 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters, with an average beat of 3.12%. The share price of the company has increased 21.2% year to date.

Wall Street's Next Amazon

Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It's a once-in-a-generation opportunity to invest in pure genius.

Click for details >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Roche Holding AG (RHHBY): Free Stock Analysis Report

Allergan PLC. (AGN): Free Stock Analysis Report

Johnson & Johnson (JNJ): Free Stock Analysis Report

Amgen Inc. (AMGN): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.



This article appears in: Investing , Business , Stocks
Referenced Symbols: RHHBY , AGN , JNJ , AMGN


More from Zacks.com

Subscribe






Zacks.com
Contributor:

Zacks.com

Equity Research








Research Brokers before you trade

Want to trade FX?





Find a Credit Card

Select a credit card product by:
Select an offer:
Search
Data Provided by BankRate.com