Published On: Sun, Jul 29th, 2018

CHMP recommends AstraZeneca lung cancer drug Imfinzi EMA approval

Tagged with: | | | | | | | |

Update on EMA approval : The (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the approval of AstraZeneca Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung (NSCLC).

The committee has recommended Imfinzi EMA approval of the AstraZeneca immunotherapy for the treatment of the type of NSCLC in adults whose tumors express PD-L1 on ≥1% of cells and whose condition has not progressed after platinum-based chemotherapy and radiation therapy (CRT).

Imfinzi EMA Approval Update

AstraZeneca reported that the CHMP recommendation for Imfinzi EMA approval was driven by the progression-free survival (PFS) and overall survival (OS) primary endpoints of the phase III PACIFIC trial, and post-hoc subgroup analyses by PD-L1 expression as requested by the EMA committee.

The PACIFIC trial is being held in NSCLC patients, regardless of PD-L1 status, and whose condition has not progressed after platinum-based CRT.

CHMP recommends AstraZeneca lung cancer drug Imfinzi EMA approval

CHMP adopts positive opinion over AstraZeneca drug Imfinzi EMA approval. Photo courtesy of AstraZeneca.

In the late-stage trial, the AstraZeneca lung cancer drug Imfinzi came up with a statistically-significant and clinically-meaningful improvement in both PFS and OS. AstraZeneca revealed that the recommended label reflects a majority of the patients in the PACIFIC trial with a known PD-L1 status.

CHMP’s positive opinion over the AstraZeneca lung cancer drug Imfinzi will be looked into by the European Commission which will take the final call on the Imfinzi EMA approval across 28 EU member countries along with , and Liechtenstein.

Commenting on the CHMP positive opinion over the AstraZeneca lung cancer drug Imfinzi, Sean Bohen – Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The CHMP positive opinion brings European patients closer to having a treatment following chemoradiation therapy. There have been no new treatments in this setting for decades.

“With approximately a third of European non-small cell lung cancer patients presenting with this stage of disease, we are excited by this potential new standard of care in this curative-intent setting.”

AstraZeneca Lung Cancer Drug Imfinzi

Imfinzi is a human monoclonal antibody that targets the PD-1/PD-L1 pathway to block the interaction of PD-L1 with PD-1 and CD80 proteins. Through this mechanism, the lung cancer drug counters the immune-evading tactics of the tumor while releasing the inhibition of immune responses.

In the US, the AstraZeneca lung cancer drug Imfinzi was approved in mid-February 2018 for unresectable stage III NSCLC in patients whose condition has not progressed after concurrent platinum-based CRT.

For more updates on AstraZeneca lung cancer drug Imfinzi EMA approval, keep following PharmaNewsDaily.com.

Related posts