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BMS gets OK for monthly Opdivo dosing

Analysts predict the new dosing schedule could see the pharma giant win market share

BMSThe majority of patients treated with Bristol-Myers Squibb’s checkpoint inhibitor Opdivo will receive fewer injections after the FDA cleared a four-weekly dosing regimen for the drug.

BMS said the update to the dosing schedule applies to most of the approved indications for Opdivo (nivolumab), which was previously mainly dosed every two weeks.

According to analysts, the less frequent schedule could help BMS win market share as the use of checkpoint inhibitor immunotherapy starts to shift into the maintenance and adjuvant treatment settings in cancer. It is competing in the marketplace with two other PD-1 inhibitors - Merck & Co/MSD’s Keytruda (pembrolizumab) and Roche’s Tecentriq (atezolizumab) - as well as PD-L1 inhibitors Imfinzi (durvalumab) from AstraZeneca and Merck KGaA/Pfizer’s Bavencio (avelumab).

The company’s head of US commercial operations Johanna Mercier notes that Opdivo is the first drug in the PD-1 inhibitor class to get the nod for four-weekly dosing and - along with a new, shorter (30-minute) infusion time - this means it can “now offer the most robust range of dosing options for an immuno-oncology medicine, providing enhanced flexibility to help address each patient's specific needs”.

The new monthly injection can be used in a range of cancers, including certain patients with melanoma, non-small cell lung cancer (NSCLC), head and neck, liver, bladder and kidney cancer and classical Hodgkin’s lymphoma, said BMS in a statement.

The company is maintaining its lead in the PD-1/PD-L1 category with Opdivo sales of $4.95bn last year, although fast-growing Keytruda is closing the gap with Merck posting 2017 revenues from the drug of $3.8bn, thanks in part to its leading position in the big NSCLC market.

Having a choice between the two- and four-week schedules can allow oncologists to tailor treatment more appropriately to patients’ needs, according to Jeffrey Weber, deputy director of the Perlmutter Cancer Center at NYU Langone Health in the US.

“We continuously learn new ways to individualise treatment with immuno-oncology therapies, and in my experience, what works for one patient may not be optimal for another,” he said.

“For instance, some patients may need the support of two-week visits with their healthcare team, while for others, a four-week interval may be more appropriate and better suited to their treatment needs.”

Article by
Phil Taylor

7th March 2018

From: Regulatory

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