Boehringer’s afatinib andRoche/Astellas’ Tarveca receive accelerated review process
The US FDA has fast-tracked two personalised non-small cell lung cancer (NSCLC) drugs from Boehringer Ingelheim and Roche/Astellas, putting the products on track for approval in the third quarter of this year.
Boehringer was granted priority review for its epidermal growth factor receptor (EGFR) inhibitor afatinib in NSCLC patients with locally advanced or metastatic disease who test positive for the EGFR mutation.
Between 10 and 25 per cent of Caucasian NSCLC patients are EGFR-positive, with the proportion rising to 30-40 per cent in some Asian populations.
The marketing application is based on the results of the phase III LUX-Lung 3 trial, which found that afatinib was able to increase progression-free survival by 11.1 months, significantly better than the 6.9-month increase achieved with Lilly's Alimta (pemetrexed) and cisplatin, which is currently considered the best-in-class therapy.
Boehringer filed for approval of afatinib for the NSCLC indication in Europe last August, and is also carrying out phase III trials of the drug in breast cancer and head and neck cancer.
Meanwhile, Roche and Astellas have been given a fast-track review for their EGFR inhibitor Tarceva (erlotinib) in first-line NSCLC, an indication for which it was approved in Europe in 2011. Once again approval is being sought to use the drug in patents with locally advanced or metastatic NSCLC who are EGFR-positive.
Tarceva's application comes on the back of the EURTAC trial, which found that Tarceva achieved a median PFS of 10.4 months while patients treated with two-drug combinations based on platinum drugs (cisplatin plus docetaxel, cisplatin plus gemcitabine, docetaxel plus carboplatin or gemcitabine plus carboplatin) achieved a PFS of 5.1 months.
The drug, which has been approved for second-line use in NSCLC for some time, has also been shown to be effective as a first-line therapy in the OPTIMAL study, which focused on Asian NSCLC patients.
The EGFR inhibitors as a class are credited with transforming the treatment of NSCLC, but do have a problem with side effects, particularly rash, and the development of resistance.
Afatinib is a slightly different member of the class in that its actions on EGFR are irreversible, which hypothetically means that it could be less prone to activity loss over time.