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Roche undercuts price of Bayer cancer drug after winning FDA approval

Both drugs highly effective in small subset of patients

Roche

Roche has won US Food and Drug Administration (FDA) approval for its rival to Bayer’s oncology drug Vitrakvi (larotrectinib).

The approval clears Roche’s Rozlytrek (entrectinib) for use in adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC) and people aged 12 and over with solid tumours that have a NTRK gene fusion.

Vitrakvi, which Bayer acquired from Loxo Oncology, won approval in patients with NTRK gene fusions in November. The FDA approvals of Rozlytrek and Vitrakvi cover all patients with NTRK gene fusions, regardless of where the tumour is located in the body.

Bayer has a head start over Roche and, while it is yet to disclose Vitrakvi sales figures, it has said that the commercial ramp-up is proceeding as expected.

Roche could derail Bayer’s progress, however, in part because of its willingness to compete on price. The list price for a month’s supply of Rozlytrek is just over $17,000, compared to almost $33,000 for Vitrakvi.

Both drugs have proven to be highly effective in a small subset of patients with certain biomarkers. Rozlytrek achieved overall response rates of 78% and 57% in NSCLC and NTRK gene fusion patients respectively, giving analysts confidence that the therapy would win approval and generate significant sales.

Writing earlier this year, analysts at Jefferies called Rozlytrek one of Roche’s “lower risk late-stage key oncology assets”. The analysts expect worldwide sales of the drug to peak at $700m.

To generate those sales, Roche will need to persuade physicians to test patients for the biomarkers that indicate whether Rozlytrek is likely to work.

In Japan, where Rozlytrek won approval earlier this year, the drug came to market in conjunction with a companion diagnostic developed by Roche-subsidiary Foundation Medicine.

Roche is working with Foundation Medicine to prepare a filing for FDA approval of the companion diagnostic, but for now no dedicated test is available. Vitrakvi also came to market without a companion diagnostic.

Rozlytrek and Vitrakvi are part of a wave of drugs targeting ROS1, TRK and ALK mutations. The level of activity reflects both the impressive efficacy seen to date and the rate at which patients develop resistance to the drugs.

Bayer is working on a follow-up to Vitrakvi, called BAY 2731954, that triggered responses in 45% of patients with TRK-resistance mutations who were resistant or intolerant to a prior TKI inhibitor. TP Therapeutics is developing repotrectinib for use in a similar patient population.

Article by
Nick Taylor

16th August 2019

From: Regulatory

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