Roche's Alectinib Approved in Japan - Analyst Blog

By
A A A

Roche ( RHHBY ) received positive news  when the Japanese Ministry of Health, Labour and Welfare (MHLW) approved alectinib for the treatment of patients suffering from non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase fusion gene-positive (ALK+).

The approval was based on encouraging results from a phase I/II clinical study (AF-001JP) conducted in Japan among patients whose tumors were advanced, recurrent or could not be removed completely through surgery.

The trial consisted of two phases - in phase I, the safety, tolerability, pharmacokinetic parameters and recommended dose (24 patients) of alectinib was evaluated and phase II evaluated the efficacy and safety of the recommended dose. The data from the study showed that 90% of the patients responded to the treatment with alectinib.

Alectinib will be available in Japan later this year. We note that alectinib was granted Breakthrough Therapy Designation by the FDA in Jun 2013 for patients suffering from ALK+ NSCLC who progressed on Xalkori.

Meanwhile, Roche is conducting clinical studies on a global basis to evaluate alectinib for this indication as well as in treatment-naïve patients. Roche expects to use the results of these studies for regulatory submissions in the U.S. and Europe.

We note that Roche's Avastin and Tarceva are already approved for the treatment of various types of lung cancer. The approval of alectinib in Japan and a potential approval in the U.S. and EU will further boost Roche's oncology franchise.

Roche specializes in oncology drugs. In particular, the company is a leader in breast cancer franchise and continues to innovate further to strengthen its already dominant position.

Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader healthcare sector include Abbott Labs ( ABT ), Allergan ( AGN ) and Shire ( SHPG ). All three stocks carry a Zacks Rank #2 (Buy).


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 HLDG LTD (RHHBY): Free Stock Analysis Report

ALLERGAN INC (AGN): Free Stock Analysis Report

ABBOTT LABS (ABT): Free Stock Analysis Report

SHIRE PLC-ADR (SHPG): 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 The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: RHHBY , AGN , ABT , SHPG

Zacks.com

Zacks.com

More from Zacks.com:

Related Videos

Stocks

Referenced

Most Active by Volume

270,887,127
    $93.89 unch
225,243,115
  • $40.93 ▼ 2.74%
135,900,109
  • $47.52 ▲ 1.80%
89,467,924
  • $5.35 ▼ 1.11%
85,105,358
  • $16.95 ▼ 0.53%
80,748,539
  • $39.80 ▼ 4.21%
68,491,586
  • $3.57 ▼ 1.79%
62,097,356
  • $100.96 ▼ 0.82%
As of 9/19/2014, 04:15 PM

Find a Credit Card

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