FDA grants priority review of acalabrutinib for second-line treatment of MCL

 

The Food and Drug Administration has granted a priority review for acalabrutinib, a Bruton tyrosine kinase inhibitor, for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

The new drug application is based on results from the phase 2 ACE-LY-004 trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory MCL who had received at least one prior therapy.

Results from the trial will be submitted for presentation at a forthcoming medical meeting, makers of the drug AstraZeneca said in a press release announcing the priority review. The company also has a phase 3 trial underway evaluating acalabrutinib as a first-line treatment for patients with MCL.

[email protected]

On Twitter @NikolaidesLaura

 

The Food and Drug Administration has granted a priority review for acalabrutinib, a Bruton tyrosine kinase inhibitor, for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

The new drug application is based on results from the phase 2 ACE-LY-004 trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory MCL who had received at least one prior therapy.

Results from the trial will be submitted for presentation at a forthcoming medical meeting, makers of the drug AstraZeneca said in a press release announcing the priority review. The company also has a phase 3 trial underway evaluating acalabrutinib as a first-line treatment for patients with MCL.

[email protected]

On Twitter @NikolaidesLaura

 

The Food and Drug Administration has granted a priority review for acalabrutinib, a Bruton tyrosine kinase inhibitor, for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

The new drug application is based on results from the phase 2 ACE-LY-004 trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory MCL who had received at least one prior therapy.

Results from the trial will be submitted for presentation at a forthcoming medical meeting, makers of the drug AstraZeneca said in a press release announcing the priority review. The company also has a phase 3 trial underway evaluating acalabrutinib as a first-line treatment for patients with MCL.

[email protected]

On Twitter @NikolaidesLaura