Pfizer to seek US approval for crizotinib next year
pharmafile | November 1, 2010 | News story | Research and Development, Sales and Marketing | FDA submission, NSCLC, Pfizer, crizotinib, lung cancer, non-small cell lung cancer
Pfizer will submit its lung cancer candidate crizotinib to the FDA for US approval in the first half of next year.
Crizotinib is being tested as a second and third line treatment for non-small cell lung cancer (NSCLC) patients expressing the anaplastic lymphoma kinase (ALK) mutation, believed to be a key driver in tumour development.
Currently, only 3-5% of NSCLC patients are thought to express the ALK mutation, but this may increase as gene testing continues.
A Part 2 expansion cohort of a phase I study of the drug was recently published in the New England Journal of Medicine.
It found 57% of ALK-positive advanced NSCLC patients treated with crizotinib had either a complete (one patient) or partial (46 patients) response to treatment. An additional 33% had their condition stabilised.
Dr Mace Rothenberg, senior VP of clinical development and medical affairs for Pfizer’s Oncology Business Unit, said: “While this is a phase I study, the high response rates observed in patients with ALK positive NSCLC who received crizotinib suggest that we may be one step closer to the development of ‘precision’ or ‘personalised’ cancer treatments that target specific genetic factors that drive certain tumours.”
Non-small cell lung cancer remains a difficult and largely unmet medical need and efforts towards tackling the disease are becoming more personalised.
Dr Eunice Kwak, department of medicine at Harvard Medical School, and lead author of the study, said: “As we’re discovering more about lung cancer, we have confirmed the fundamental need to test tumours for molecular changes, like the ALK fusion gene, so we can better identify the patients who may benefit from certain treatments.”
Study A8081001 is a two-part, phase I, open-label, multi-centre study evaluating crizotinib in patients with solid tumours being tested on 82 patients.
Additional trials of crizotinib include a randomised, phase III open-label study – PROFILE 1007 – evaluating the safety and anti-tumour activity of the drug versus standard of care chemotherapy in patients with previously treated ALK-positive advanced NSCLC.
Pfizer said it was continuing to study crizotinib in ongoing clinical development programmes but confirmed plans to submit the drug’s encouraging data to the FDA “in the first half of next year”.
Drug resistance in NSCLC
In common with current NSCLC cancer treatments on the market, crizotinib has succumbed to a small number of drug resistant patients.
In the phase I study a team of doctors led by Young Lim Choi of the University of Tokyo reported on a patient who developed two independent mutations that made the tumour resistant to the drug.
Dr Hiroyuki Mano of the University of Tokyo, told Reuters the news was both good and bad.
“It’s bad in that there may be some refractory population. But it’s good that we know the resistant mutations, so the next generation of ALK inhibitors will use that information to make a less refractory drug in the very near future.”
AstraZeneca’s NSCLC drug Iressa (gefitinib), that targets the more common EGFR mutation, has also seen drug resistance whilst on the market.
Boehringer Ingelheim is now developing its own second line drug Tovok (afatinib) to meet this resistance, with results showcased at this years European oncology congress ESMO.
Ben Adams
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