Home health remedies AstraZeneca eyes less-frequent Imfinzi dosing with FDA ‘priority’ boost

AstraZeneca eyes less-frequent Imfinzi dosing with FDA ‘priority’ boost

9
0
SHARE

Merck’s Keytruda recently became the only member of the PD-1/PD-L1 class with an FDA nod for less-frequent dosing—but AstraZeneca doesn’t intend to let it keep that title for long.

The FDA Tuesday handed the British drugmaker a priority review for a new four-week dosing regimen for blockbuster Imfinzi in Stage 3 non-small cell lung cancer and bladder cancer. The company is expecting a verdict from regulators in the fourth quarter, it said.

RELATED: Merck grabs FDA green light for less-frequent Keytruda dosing regimen

Virtual Event

DEVELOP A UNIFIED SCIENTIFIC VOICE

Learn how to streamline medical communications and align tactics and objectives within your organizations by attending the virtual Medical Affairs Strategic Summit (MASS).

If AZ can snag a green light for the new dosing schedule, it would cut patient visits to treatment centers by half. Currently, Imfinzi patients receive the drug every two weeks at a weight-based dose in those two indications. Reducing those visits would not only up Imfinzi’s convenience factor and free up treatment center resources, but keep vulnerable patients home amid the COVID-19 pandemic, too.

A new nod could also give the drug a leg up on its competition. While bladder cancer is a smaller arena, it’s also immuno-oncology’s most crowded: Five drugmakers in the class bear approvals for their contenders. One of them is Merck’s Keytruda, which in April nabbed its own long-acting nod for use every six weeks. But every-four-weeks clearance would still lift Imfinzi above the rest of the bladder cancer pack.

The much larger revenue driver for Imfinzi is its indication in Stage 3 NSCLC post-chemo and radiation therapy; that approval has helped the drug reach blockbuster heights, with $492 million in sales last quarter alone. Right now, in-class competition isn’t imminent, but the new dosing flexibility will only raise the bar for AstraZeneca’s future competitors.

RELATED: AstraZeneca’s Imfinzi gets FDA green light to challenge Roche in small cell lung cancer

Meanwhile, the new fixed-1,500mg dose is already in use in small cell lung cancer, a field where AstraZeneca scored an FDA go-ahead this March. Results from the company’s pivotal small-cell trial in that field, dubbed Caspian, helped form the basis for Tuesday’s priority review designation.

Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here

3 × 1 =