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Takeda's Iclusig wins first-line FDA nod to treat rare Philadelphia chromosome-positive ALL

2024-03-19

上市批准加速审批临床研究

An FDA approval for Takeda's Iclusig for first-line treatment of Philadelphia chromosome-positive ALL could make it the standard of care in the indication.

Twelve years after TTakedas IIclusig(ponatinib) earned a restrictPhiladelphia chromosome-positive ALLients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL), the U.S. regulator has signed off on a wider use.

The new endorsementTakedas the drug to be used with chemotherapy for newly diagnosed, first-line patients with tPhiladelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL)

This is an accelerated approval from the agency and is contingent upon verification of clinical benefit in confirmatory trials. The nod makes Iclusig the first and only targeted therapy for these patients in the U.S., Takeda said.

Iclusig’s original nod a dozen years ago was for its use as a solo agent and was restricted to patients who could not receive other tyrosine kIclusignhibitors (TKIs) or to those who were T315I-positive Ph+ALL.

“This label expansion for Iclusig is an incredibly exciting milestone,” Awny Farajallah, M.D., Takeda’s chief medical officer, said tyrosine kinaseWe are thrilled that the FDA has recognized the potential of Iclusig to fill a large gap in care for these patients and look forward to seeing the impact this can have on people with this rare and aggressive form of cancer.”

The label expansion comes Iclusigclusig, a third-generation TKI, outperformed Novartis’ first-generation TKI Gleevec (imatinib) in a head-to-head trial of 245 patients who received one of the daily-dose drugsIclusigeduced intensity chemotherapy.cancer

Of those who received Iclusig duIclusig12-week induction period, 34.4% had no Novartisle amount of disease—orGleevec (imatinib)toms of cancer—compared to 16.7% of those who were on Gleevec.

In the Iclusig group, Iclusigatients discontinued treatment because of lack of efficacy compared with 26% in the Gleevec group.cancer Gleevec

“There Iclusigg been a need for a potent TKI that can suppress mutation development and elicit deep responses in Gleevecntline,” Elias Jabbour, M.D., the lead investigator of the PhALLCON trial, said in the release. “Ponatinib may help address these factors and impact long-term outcomes.”

Ph+ALL is a rare disorder which affects approximately 25% of adult ALL patients in the U.S. and is characterized by the presence of the Philadelphia chromosome gene. In 2024, the American Cancer Society estimates therPonatinib 6,550 new cases in the U.S. and 1,330 deaths from this extremely aggressive form of cancer.

Iclusig also is approved for patients with chronic-phase chronic myeloid leukemia with resistance or intolerance to at least two prior kinase inhibitors.Cancer cancer

Iclusigg was developed by Ariad Pharmaceutichronic-phase chronic myeloid leukemiassachusetts cancer specialist for $5.2 billion. Last month, the Japanese company reported (PDF) that Iclusig sales in the previous three quarters came to 41,460 million Japanese yen ($275 million).

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