Takeda R&D chief Andy Plump hit the money shot with a head-to-head Phase III study pitting Alunbrig (brigatinib) against Pfizer’s Xalkori in a group of ALK+ non-small cell lung cancer patients.
Researchers say their drug hit the primary endpoint on progression-free survival. Currently not approved for frontline use, the drug was tested in patients who had not yet received an ALK inhibitor.
Approved last April for treatment-resistant cases of ALK+ NSCLC, Takeda has been pursuing evidence that their drug can garner more than a billion dollars a year in sales, a stretch above the $500 million to $800 million mark that analysts have projected. And now they plan to hustle up a supplemental approval to help make that forecast a reality.
Takeda acquired the drug in the $5.2 billion Ariad buyout, making this a particularly important win for the R&D team. Now in the process of acquiring Shire, Takeda’s growing oncology group is centered around Boston/Cambridge.
We’ll get the data at an upcoming meeting, which should provide greater clarity on the market potential. While NSCLC is quite common, ALK mutations account for about 3% to 5% of the patient population.
Jesús Gomez-Navarro, Takeda’s head of oncology clinical research and development, noted that they were encouraged by the data and “look forward to beginning discussions with regulatory authorities as we seek to expand Alunbrig’s indication into the frontline setting.”
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