Eli Lilly’s Jaypirca Granted Traditional FDA Approval In Treating Certain Cancers

• The U.S. Food and Drug Administration on Wednesday granted traditional approval to Eli Lilly said on Wednesday that the fresh approval expands the Jaypirca label to include patients earlier in their treatment course. 
• Approved is based on results from a late-stage trial that enrolled 238 patients who were previously treated with a covalent BTK inhibitor.
• Patients showed an improvement in progression free survival in the study.

The U.S. Food and Drug Administration on Wednesday granted traditional approval to Eli Lilly and Company’s Jaypirca for pre-treated adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The agency approved the drug for patients who were previously treated with a covalent BTK inhibitor, a class of drugs that permanently bind to and block the Bruton's tyrosine kinase (BTK) protein, which is crucial for the survival of certain B-cell cancers like chronic lymphocytic leukemia.

In December 2023, the FDA had granted accelerated approval to Jaypirca for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy. Accelerated approval is a conditional approval that requires the drug maker to conduct confirmatory studies after the drug is on the market to verify the clinical benefit.

Implications Of Traditional Approval

Lilly said on Wednesday that the fresh approval expands the Jaypirca label to include patients earlier in their treatment course.

The approval is based on results from a late-stage trial that enrolled 238 patients who were previously treated with a covalent BTK inhibitor. Patients were randomized to receive either Jaypirca or investigator’s choice of idelalisib plus a rituximab product (IR) or bendamustine plus a rituximab product (BR).

Median progression free survival or time from the start of treatment until disease progression or death was 11.2 months in the Jaypirca arm and 8.7 months in the investigator’s choice of IR/BR arm in the study.

"This label expansion allows physicians to use Jaypirca directly after a covalent BTK inhibitor, the setting where we have always believed it has its most unique potential impact for patients," said Jacob Van Naarden, executive vice president and president of Lilly Oncology.

How Did Stocktwits Users React?

LLY shares traded nearly 1% lower at the time of writing. On Stocktwits, retail sentiment around LLY stayed within the ‘extremely bearish’ territory over the past 24 hours while message volume fell from ‘normal’ to ‘low’ levels.

A Stocktwits expressed disappointment at the stock trading in the red.

Another termed the stock a ‘strong sell’, while reiterating support for Lilly’s rival and Danish drugmaker Novo Nordisk.

LLY stock is up by 35% this year and by about 28% over the past 12 months. 

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