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Onyx’s Myeloma Drug Kyprolis Fits ODAC’s View On Accelerated Approval

 
• By Sue Sutter

FDA’s Oncologic Drugs Advisory Committee overwhelmingly endorsed the second-generation proteasome inhibitor for accelerated approval in the relapsed/refractory population. Onyx’s reliance on a single-arm study was appropriate given the lack of treatment options in a heavily pre-treated population, said ODAC members, who also looked favorably upon the company’s advanced plans for confirmatory trials.

Onyx Pharmaceuticals Inc.’s NDA and clinical development program for the investigational multiple myeloma drug Kyprolis (carfilzomib) could be a textbook example of an appropriate accelerated approval plan, satisfying all of the criteria that have been laid out by FDA’s Oncologic Drugs Advisory Committee, panel members said at their June 20 meeting.

Although Onyx sought approval on the basis of one single-arm, Phase II trial, rather than a randomized study generally preferred...

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More from United States

CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 
• By Sarah Karlin-Smith

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 
• By Derrick Gingery

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.

More from North America

Merck’s Clesrovimab Vote Reflects New ACIP Members’ Skepticism

 
• By Sue Sutter

The new Advisory Committee on Immunization Practices members endorsed Merck & Co.’s monoclonal antibody for RSV prevention, but some questioned its use in healthy babies and potential interactions with vaccines given at the same time.

Oz Says Big PBMs Have ‘Window’ to Quit Rebate System on Their Own

 
• By Leslie Small

CMS Administrator Mehmet Oz said PBMs may deserve "one last chance" to fix the rebate system before federal regulations and legislation are enacted.

Canada Unveils Draft List of Essential Drugs For Universal Pharmacare

 
• By Neena Brizmohun

The list of essential prescription drugs and related products will shape Canada’s first national formulary for the country’s universal pharmacare program.