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Friday, 12/09/2016 3:49:06 AM

Friday, December 09, 2016 3:49:06 AM

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Novartis Lung Cancer Drug Succeeds in Trial (NVS)

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Novartis AG (NVS) said its lung-cancer drug Zykadia is effective in chemotherapy in a Phase 3 study for treating patients with anaplastic lymphoma kinase-positive nonsmall cell lung cancer. The Phase 3 trial result showed that Zykadia was twice as effective in slowing the progression of the lung cancer disorder compared to chemotherapy. Zykadia demonstrated 16.6 months of progression-free survival (PFS) compared to 8.1 months for chemotherapy. PFS is the length of time during and after treatment that a patient lives with the disease but it does not get worse. (See also: Novartis, Kite In CAR-T Cancer Drug Race.)

Drug Shown Safe and Effective In Trial
The Zykadia drug also shown to be safe in the late-stage study. Zykadia works by inhibiting the anaplastic lymphoma kinase gene, which combines with other genes to develop into an abnormal protein that fuels cancer growth. Zykadia has already secured accelerated approval status in the U.S. as a second-line therapy for patients who fail standard initial therapy (which is Pfizer Inc.'s (PFE) Xalkori), or whose cancer has progressed. The drug also received a similar conditional approval in the EU. The results will help Zykadia be considered as a potential first-line treatment over standard chemotherapy. (See Novartis Leukemia Drug Gets FDA Priority.)

Small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) are two types of lung cancers. NSCLC is the most common type in which cancer cells build in the lung tissues. It usually grows and spreads more slowly than SCLC. This year, about 225,000 individuals are expected to be diagnosed with lung cancer, which includes the bulk of NSCLC patients.

Novartis’ Zykadia competes against Roche Holding AG's Alecensa drug, which leads the race for approval as the first line treatment for ALK+NSCLC. Ariad Pharmaceuticals Inc. (ARIA) also has the early-stage Brigatinib drug in the same space. (See also: Ariad Cancer Drug Shows Some Early Promise.)

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