Roche takes on Pfizer with new lung cancer data
- Roche’s big biotech unit Genentech reported Monday morning its ALK-inhibitor Alecensa (alectinib) beat out Pfizer’s Xalkori (crizotinib) in a sub-population of lung cancer patients.
- The drug was granted accelerated approval in the U.S. in December 2015 for ALK-positive non-small cell lung cancer (NCSLC) patients that have previously failed on Xalkori. The ALEX study is part of the company’s push to convert the Alecensa nod to a full approval.
- Further details about the data will be presented at an upcoming medical meeting. Roche plans to file the data with the Food and Drug Administration.
Roche garnered approval for Alecensa in late-2015, but the go-ahead was based on mid-stage data and required the big pharma to prove that the drug is as effective as those studies showed.
That’s where the ALEX study comes in. Alecensa was only given an approval for those patients who had already failed on Pfizer’s Xalkori. So, Roche decided to conduct a Phase 3 study in ALK-positive patients that compared the two drugs head-to-head. While Roche didn’t give the particulars of the data, they did reveal that Alecensa was superior to Xalkori as a first-line treatment.
Expect Roche to push ahead rapidly to seek approval for first-line treatment, and for it to make a big commercial push to unseat Xalkori.
Alecensa was approved under similar conditions in Europe and the ALEX study will also work to fulfill a post-marketing requirement for that approval as well.
Xalkori brought in $561 million for Pfizer in 2016, up 15% year over year.
- Roche Press release
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