- Roche’s Q2 Results Reaffirm Our Bullish Stance
- Why Is Roche A Market Leader In Oncology Therapies?
- FDA Approved Tecentriq – How It Affected Our Price Estimate For Roche?
- Is The Biosimilar for Roche’s Herceptin A Major Threat?
- Roche’s Q1 2016 Earnings Support Our Bullish Stance
- What To Expect From Roche’s Q1 2016 Earnings?
Roche Group (PINK:RHHBY) is scheduled to release new data for some of its established and experimental cancer drugs at the European Cancer Congress (ECC) in Amsterdam. The congress will be in session from September 27 to October 1, 2013.
While all the data released by the company is important, we are especially keen on hearing about the performance of some of Roche’s new and experimental drugs. These drugs are likely to be important for the future growth of the company, especially when some of its established drugs start losing patent rights around the globe. On this note, let us take a look at some of the newest and most promising drugs in Roche’s oncology pipeline.
Perjeta is a new drug for HER2-positive breast cancer. It was launched in the U.S. last year for treating advanced cases of this disease and received a regulatory approval in Europe for the same in March 2013.   The sales of the drug for the first six months of 2013 crossed 108 million Swiss Francs.
Recently, the FDA’s Oncologic Drugs Advisory Committee (ODAC) also recommended that Perjeta should be reviewed on priority basis for treating early stages of HER2-positive breast cancer. If approved, it will be the first drug to be sanctioned by the regulatory body as a pre-surgical treatment for this type of breast cancer. 
Kadcyla is another breast cancer drug from Roche. It was launched in the U.S. this year in February and in Switzerland in May.  Its sales for the first six months of this year stood at around 83 million Swiss Francs.
This month, Kadcyla received a regulatory approval in Japan.  A regulatory approval in Europe may also be close as it recently received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP).  More data regarding Kadcyla’s efficacy is expected to be revealed by Roche at the ECC.
Alectinib is a promising new medicine for the treatment of non-small cell lung cancer (NSCLC). It was recently granted the status of a “breakthrough” drug by the FDA.  This status is awarded to speed up the development and review process of drugs that demonstrate substantial improvement over existing therapies of life threatening diseases. At the ECC, Roche will be presenting the data based on which the FDA granted Alectinib this coveted designation.
GA-101 is another one of Roche’s experimental “breakthrough” drugs. It is being tested as a cure for blood cancer, and was recently proven to be more effective than Rituxan (best-selling blood cancer drug, also from Roche). 
In July, the FDA also granted this drug a priority review for the treatment of chronic lymphocytic leukemia, one of the most common types of blood cancer. Roche expects the FDA approval to come by the end of this year, and has also filed for approval in Europe. 
MPDL3280A is a new type of cancer treatment that enables the human immune system to attack and destroy cancers. If successful, this investigational medicine could have applications in multiple cancer areas. At the ECC, Roche is going to present data for the efficacy of this drug in patients with non-small cell lung cancer. 
- FDA approves Perjeta (pertuzumab) for people with HER2-positive metastatic breast cancer, Press Release, June 11, 2013 [↩]
- Roche obtains EU approval for PERJETA, a new personalised treatment for aggressive type of breast cancer, Press Release, March 5, 2013 [↩]
- Roche Perjeta Wins Panel Backing for Early Breast Cancer, Bloomberg, September 13, 2013 [↩]
- FDA approves new treatment for late-stage breast cancer, FDA, February 22, 2013 [↩]
- Chugai Pharma receives Japanese approval for anti-cancer agent Kadcyla, Pharmabiz, September 23, 2013 [↩]
- CHMP grants positive opinion for Roche’s Kadcyla, the first antibody-drug conjugate for advanced HER2-positive breast cancer, Press Release, September 20, 2013 [↩]
- Roche lung cancer drug bags another ‘breakthrough’ at the FDA, FierceBiotech, September 23, 2013 [↩]
- Roche’s obinutuzumab (GA101) delayed disease progression longer than MabThera/Rituxan in people with one of the most common forms of blood cancer, Roche, July 24, 2013 [↩]
- FDA grants Roche’s obinutuzumab (GA101) Priority Review for previously untreated chronic lymphocytic leukemia (CLL), Press release, July 3, 2013 [↩]
- Roche to share important oncology data at European Cancer Congress (ECC), Press Release, September 23, 2013 [↩]