- Clovis Oncology's rociletinib is targeted for second-line treatment of lung cancer in patients whose EGFR genes carry the T790M mutation. AstraZeneca (AZ) has a drug in development for lung cancer with a similar profile—AZD9291.
- Not only has rociletinib been granted Priority Review in the U.S., but it has also been put into the European Medicine Association's (EMA) accelerated assessment program, which decreases review time from 210 days to 150 days.
- In addition to a head-on competition between Clovis and AZ in the area of lung cancer, the two companies are also both working on PARP inhibitors for treatment of advanced ovarian cancer.
Given the ongoing need for additional treatment options for lung cancer, as well as ovarian cancer, the ability to expedite the approval process is critical. Why are so many new drugs needed when there is already a strong armamentarium of drugs for treating lung cancer, including old-line chemotherapeutic agents, tyrosine kinase inhibitors, various types of combination therapies and the strong-hold immuno-oncologics, Opdivo (nivolumab) and Keytruda (pembrolizumab)?
Because...despite these options, the American Cancer Society reports that the five-year survival rate for lung cancer is 15%, though when the cancer is detected early that rate rises to 49%. One major challenge is that there are many different types of oncogenetic changes in lung cancer, and those need to be addressed in order to successfully quell the cancer—if only for a period of months and hopefully permanently. In addition to p53 and LKB1 mutatations, mutations in epidermal growth facror receptors (EGFRs) are frequently present in patients with lung cancer.
Clovis's rociletinib, which targets overexpressed EGFR in these patients, has been associated with increased progression-free survival (PFS) of at least eight months in lung cancer patients—with AZ's drug also showing strong results.
Priority review speeds up a 10-month review period by four months, and in the case of the accelerated assessment program, the process is sped up by 60 days. That may not seen like a lot in the broad scope of things, but when you're talking about patients whose lives are measured in a period of months left to live, it could make a huge difference.