Boehringer nears European approval for first cancer drug
pharmafile | July 29, 2013 | News story | Sales and Marketing | Boehringer, Cancer, FDA, afatinib
Boehringer’s first cancer drug is just months away from being approved in Europe after a committee for the EMA gave the treatment a positive recommendation.
Giotrif (afatinib), the first irreversible ErbB family blocker, received a yes from the CHMP for the treatment of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor naive adult patients, with locally advanced or metastatic non-small cell lung cancer (NSCLC) and activating EGFR mutations.
This recommendation will now be passed onto the European Commission, which should approve the drug within three months.
Prof Klaus Dugi, corporate senior VP of Medicine at Boehringer, said: “Boehringer Ingelheim welcomes the decision by the CHMP which follows the recent FDA approval of afatinib. We look forward to making afatinib available soon to patients with EGFR mutation positive lung cancer in Europe.
“Afatinib irreversibly blocks EGFR and other relevant members of the ErbB Family and has demonstrated a meaningful therapeutic benefit in clinical trials.”
The drug was approved by the FDA in mid-July under the patent name Gilotrif for the first-line treatment of patients with NSCLC whose tumours have spread and express EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test.
It will compete with Roche’s cancer pill Tarceva, which in May was approved by the FDA for first line treatment of patients with NSCLC.
As a second, third and a maintenance therapy for the disease, Tarceva generated over $1.4 billion in 2012 sales for the Swiss firm.
The drug also comes with a companion diagnostic, called the cobas EGFR Mutation Test, which is developed by Roche’s medical devices unit. But Gilotrif represents an advance over its ‘first generation’ EGFR rival in that it blocks a wider range of targets, and is the first irreversible blocker.
This means that BI’s drug could also be given to patients who develop a ‘resistance’ to the first generation EGFR blockers, a common problem with personalised medicines.
String of recommendations
Including Giotrif the CHMP made eight recommends in all at the end of July. This included three drugs for type 2 diabetes: Incresync, Vipdomet and Vipidia, while Ultibro Breezhaler and Xoterna Breezhaler also received positive opinions from the Committee for the treatment of COPD.
Tybost should be granted a marketing authorisation for HIV, according to the Committee, which also also gave a positive recommendation for the approval of Grastofil, a biosimilar medicine for the treatment of neutropenia.
Ben Adams
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