FDA is speeding review of lung cancer drugs
Another lung cancer drug granted a speedy review at the FDA, potentially bringing life-saving treatments to patients more quickly.
While the FDA is often seen as the last hurdle to clear before a new drug is available for patients, the government agency responsible for our health and safety is shortening its lengthy approvals process to make newer, more effective drugs available to the patients who need them. The FDA has three tracks to accelerate approval of new drugs for patients with serious diseases, including lung cancer: Fast Track, Accelerated Approval, and Priority Review. Over a ten year period, the FDA has shortened its approvals of drugs in these priority tracks from 13.9 months to only 6.7 months.
Three notable lung cancer drugs are taking advantage of this expedited status:
Afatinib (Boehringer Ingelheim) was granted Priority Review status early 2013. Afatinib is a next-generation EGFR inhibitor, able to block EGFR and other closely related proteins. It is under review for treatment of patients with locally advanced or metastatic non-small cell lung cancer with an EGFR mutation as detected by an FDA-approved test. Clinical trials have shown patients taking afatinib as a first-line treatment lived for almost one year without their tumor growing (PFS of 11.1 months) versus just over half a year (PFS of 6.9 months) for those on chemotherapy (pemetrexed / cisplatin). Between 10-35% of Caucasian lung cancer patients (higher in Asian patients) have tumors with EGFR mutations. The FDA is expected to make a decision on this drug in the third quarter of 2013.
Tarceva (Roche and Astellas), an EGFR inhibitor currently approved as second line therapy for patients with NSCLC after chemotherapy, was granted Priority Review as a first line treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR activating mutations as detected by an approved test. In these patients, clinical trials showed median PFS was 10.4 months in the Tarceva group and 5.1 months in the platinum-based chemotherapy group. Tarceva reduced the risk of lung cancer getting worse by 66 percent.
LDK378 (Novartis) was recently designated as a “breakthrough therapy” by the FDA. Thanks to a new law, The Food and Drug Administration Safety and Innovation Act (FDASIA), FDA can help get new drugs developed as quickly and safely as possible so they can be available to treat the patients who need them. LDK378 is an ALK inhibitor, similar to the approved Xalkori/crizotinib (Pfizer). Between 3-7% of patients with NSCLC have tumors driven by ALK mutations. Breakthrough status was granted following a Phase I study that demonstrated marked responses in a majority of patients with ALK+ lung cancers, and an 80% response rate in patients who had progressed after treatment with crizotinib. LDK378’s breakthrough status will not only expedite review, but also enable the FDA to give more guidance during development; Novartis is currently running two Phase II trials, and will initiate a Phase III trial later this year. They anticipate filing for approval in early 2014.