Emboldened by ASCO data, FDA etches speedy approval path for Iovance's cervical cancer therapy
Iovance’s promising data snapshot detailing the potential of its cervical cancer drug at ASCO has convinced the FDA to accelerate its path to approval.
On Tuesday, the drug developer said the US regulator has recommended that an ongoing mid-stage study of its experimental therapy may be sufficient to support an application to market LN-145 in patients with advanced cervical cancer.
“This feedback is encouraging. The ability to use the current study, as well as the Breakthrough Therapy designation recently granted to LN-145, allows us to plan on a path to BLA submission in the second half of 2020,” Iovance chief Maria Fardis said in a statement. The company’s shares climbed about 2.6% to $25.26 before the bell.
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