Roche fields first approval for Rozlytrek in the run-up to a showdown with Bayer, Pfizer
While it’s waiting to hear back from FDA regulators, Roche is beginning the victory lap for entrectinib in Japan.
Roche is giving Bayer a run for their money with this tumor-agnostic drug, which targets NTRK gene fusions. Now dubbed Rozlytrek, it’s sanctioned to treat adult and pediatric patients in Japan with neurotrophic tyrosine receptor kinase fusion-positive, advanced recurrent solid tumors.
The Swiss pharma giant got its hands on entrectinib back in December 2017, when Bayer was the big partner to Loxo Oncology, via a $1.7 billion acquisition of Ignyta. It paid 74% premium on the stock for a biotech that’s distinguished itself on the forefront of precision medicine.
Loxo has since been acquired by Eli Lilly in a $8 billion deal and transferred the remaining rights to its drug, Vitrakvi, to Bayer, together with a next-gen TRK inhibitor conceived for potential resistance. As Eli Lilly focuses on Loxo’s wholly owned RET asset, it also stands to earn royalties from product sales.
While NTRK indications could run from breast, cholangiocarcinoma, colorectal, gynaecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma to thyroid cancers, they weren’t all that Roche was eyeing. Entrectinib was also designed to target ROS1 fusion genes, which is believed to drive a thin slice of all NSCLC cases.
In the latest data cut presented at ASCO, Roche’s Genentech noted that their drug scored 11 responses out of 11 children and adolescents with “solid tumors with and without neurotrophic tyrosine receptor kinase (NTRK), ROS1 or anaplastic lymphoma kinase (ALK) gene fusions.” Two of the patients had a complete response.
Within that niche, it will be facing off another rival in Pfizer, whose Xalkori is the standard treatment in ROS1 positive patients and who boasts of a recent approval for Lorviqua, also a small molecule inhibitor of ROS1 and ALK.
The FDA has granted a breakthrough therapy designation to the drug as well as priority reviews for both the NTRK and ROS1 labels, with a decision expected by August 18.