EMA to review two new Pfizer cancer drugs
pharmafile | August 19, 2011 | News story | Sales and Marketing | Cancer, Pfizer, bosutinib, crizotinib
The EMA has accepted Pfizer’s regulatory submissions for two of its new cancer compounds.
The first is its much-lauded crizotinib, an oral, first-in-class anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of patients with previously treated ALK-positive advanced non-small cell lung cancer (NSCLC).
The second is its investigational compound bosutinib, for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia (CML) in the chronic phase.
Dr Andreas Penk, president of Pfizer Oncology Europe, said: “With the EMA submissions for crizotinib and bosutinib, we are one step closer to potentially bringing two promising agents to patient populations in areas of significant unmet medical need.
“These filings underscore Pfizer’s commitment to delivering innovative therapeutic treatment options targeting various tumor types and improving the outcome for cancer patients worldwide.”
In the US Pfizer has already filed crizotinib with the FDA under a priority review, meaning the regulator could approve it as early as this November.
The drug has also been filed with the Japanese Ministry of Health, Labour and Welfare (MHLW) who, like its US counterpart, granted crizotinib orphan drug status in January this year.
By targeting the ALK mutation, the drug can only help around 1-5% of all NSCLC patients, but this could increase as genetic testing improves.
There is currently no other drug targeting this particular mutation in late-stage NSCLC, so even though it is a small patient population, it would still have the market to itself if it is approved.
Bosutinib is an investigational oral dual Src and Abl kinase inhibitor with minimal inhibitory activity against c-kit and PDGFR.
It is believed that by dual inhibition of the Src and Abl tyrosine kinases, bosutinib may inhibit signaling in CML cells that allows the cells to grow, survive and reproduce.
The drug will have a more crowded market to contend with, as the EMA and FDA have already long approved Novartis’s Glivec (imatinib) as a first-line treatment of the disease, and Tasigna (nilotinib) as a second-line option for Ph+ CML patients in chronic or accelerated phases.
In a recent head-to-head phase III with Glivec, a significantly higher proportion of patients with newly diagnosed chronic myeloid leukaemia who were treated with bosutinib (39%) experienced a major molecular response (MMR), a secondary endpoint, compared with patients treated with imatinib (26%).
The drug did not, however, reach its primary endpoint of superior complete cytogenetic response (CCyR) rate at one year versus Glivec (70% versus 68%, respectively).
Ben Adams
Related Content
Central nervous system cancer metastases – the evolution of diagnostics and treatment
The current forms of immunotherapy, how T cell therapy works and what the future holds
BioMed X and Servier launch Europe’s first XSeed Labs to advance AI-powered antibody design
BioMed X and Servier have announced the launch of Europe’s first XSeed Labs research project, …
T-cell therapy – the evolution of cancer treatments
The current forms of immunotherapy, how T cell therapy works and what the future holds
