Roche’s Rozlytrek (entrectinib) has been priced at about half the cost of its competitor, Vitrakvi (larotrectinib), according to reports. Rozlytrek comes with an estimated price tag of $17,000 a month, while Vitrakvi, manufactured by Bayer and Eli Lilly, will set patients back about $33,000 a month.
The Food & Drug Administration (FDA) announced its accelerated approval of Rozlytrek on Aug. 15. According to the FDA, Rozlytrek is indicated for “adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments.” The drug was also approved for adults with non-small cell lung cancer (NSCLC) with metastatic ROS1-positive tumors.
#OncoAlert Entrecrinib approves today for ROS1 positive NSCLC and approved for NTRK+ tumors (tumor agnostic). Great to have a highly CNS penetrant option available. #LCSM https://t.co/QAyjn04BBM’s-Rozlytrek-entrectinib-People-ROS1-Positive
— Stephen V Liu (@StephenVLiu) August 15, 2019
Rozlytrek received the FDA’s greenlight following the Phase II STARTRK-2, Phase I STARTRK-1, and Phase I ALKA-372-001 trials, and the Phase I/II STARTRK-NG study. According to a press release from the company, Roche’s drug successfully shrank tumors in 78% of NSCLC patients. Duration of response varied, from 1.8 months to more than three years. Tumors shrank in 57% of patients with NTRK gene fusion-positive, locally advanced, or metastatic solid tumors.
— Madeleine Armstrong (@ByMadeleineA) August 16, 2019
“Rozlytrek’s FDA approval for two rare types of cancer is an important advance for patients, combining a targeted medicine and genomic testing to bring this new treatment option to patients who are waiting,” Sandra Horning, MD, chief medical officer and head of global product development for Roche, in a press release. “Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has also shown responses in these rare cancer types that have spread to the brain.”
— Andrew Merron (@Andrew_Merron) August 19, 2019
Despite the fact that Rozlytrek has a wider treatment range, Evercore ISI analyst Umer Raffat told Reuters that Rozlytrek and Vitrakvi have different safety profiles. Raffat called the staggering price difference an “interesting competitive dynamic.”
According to their respective FDA labels, Rozlytrek and Vitrakvi come with significantly different risks. The most frequently reported adverse reactions associated with Vitrakvi were fatigue, nausea, dizziness, vomiting, increased AST, cough, increased ALT, constipation, and diarrhea. Rozlytrek’s most common adverse reactions included all of the same ones as Vitrakvi (except increased AST and ALT), and in addition was linked to dysgeusia, edema, dysesthesia, dyspnea, myalgia, cognitive impairment, increased weight, pyrexia, arthralgia, and vision disorders. Vitrakvi’s label warns of neurotoxicity, hepatotoxicity, and embryo-fetal toxicity. Rozlytrek similarly cautions of hepatotoxicity and embryo-fetal toxicity—as well as congestive heart failure, central nervous system effects, skeletal fractures, hyperuricemia, QT interval prolongation, and vision disorders.
Like Rozlytrek, Vitrakvi received accelerated approval from the FDA, but in 2018 and following three clinical trials. The studies included 55 patients (children and adults) with “an identified NTRK gene fusion without a resistance mutation and were metastatic or where surgical resection was likely to result in severe morbidity” who were not responding to other treatments. The FDA reported at the time of the drug’s approval an overall response rate of 75%; 73% of responses continued at six months, and 39% continued for at least one year.