Published On: Sat, Feb 25th, 2017

Novartis lung cancer drug Zykadia gets US FDA priority review

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Swiss pharma has announced that its lung drug (ceritinib) has been granted the FDA priority review for its expanded use as the first-line for lung cancer patients with certain conditions.

The expanded use is for metastatic (NSCLC) patients whose tumors were detected by an approved FDA test to be positive to the anaplastic lymphoma kinase (ALK) receptor.

Novartis lung cancer drug, Zykadia has also been granted the FDA breakthrough therapy designation for the first-line option in treating patients having ALK+ metastatic NSCLC with secondary malignant growths in the brain.

Novartis HQ

Novartis headquarters in Basel, Switzerland. Photo courtesy of Andrew- from Flickr/

Commenting on the lung cancer drug Zykadia’s priority review designation in the US, , Global Head Drug Development and Chief Medical Officer at Novartis, said: “We are committed to advancing our understanding of mutation-driven lung cancer, where there continues to be significant unmet need.

“Today’s Priority Review of Zykadia for newly diagnosed patients with ALK+ metastatic NSCLC, including Breakthrough Therapy designation for those with brain metastases, brings us closer to delivering the right treatment to the right patient at the right time.”

The developments in the lung cancer drug case come after its supplemental New Drug Application (sNDA) was accepted by the US regulator for filing.

Novartis said that the SNDA submission was made based on the results from a phase 3 study of the lung cancer drug in a global trial called ASCEND-4. In the trial, Zykadia’s safety and efficacy was evaluated against platinum-based chemotherapy which also includes maintenance, in Stage IIIB or IV ALK+ NSCLC adult patients.

As per the results of the lung cancer drug phase 3 trial, patients subjected to Zykadia as a first-line treatment showed a median progression-free survival (PFS) of 16.6 months. On the other hand, patients treated with routine pemetrexed-platinum chemotherapy with pemetrexed maintenance as first-line treatment showed PFS of 8.1 months.

Besides, the Novartis lung cancer drug, Zykadia arm demonstrated risk reduction in PFS at 45% in comparison to the chemotherapy arm.

With the FDA priority review secured, the US regulator’s decision to approve or not of the Swiss pharma’s new lung cancer medication will be done inside six months instead of ten months from the date of filing.

And if the US regulator does approve the Novartis new lung cancer drug in the in the first-line setting, then Zykadia will turn out to be a new treatment option for the otherwise untreated ALK+ metastatic NSCLC patients.

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