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LONDON, UK / ACCESSWIRE / February 24, 2017 / Active Wall St. blog coverage looks at the headline from Novartis AG (NYSE: NVS) as the Company announced on February 23, 2017, that the US Food and Drug Administration (FDA) has granted Priority Review for the expanded use of Zykadia® (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. The FDA also granted Breakthrough Therapy designation to Zykadia for the first-line treatment of patients with ALK+ metastatic NSCLC with metastases to the brain. Register with us now for your free membership and blog access at:

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One of Novartis' competitors within the Drug Manufacturers - Major space, Shire PLC (NASDAQ: SHPG), reported its unaudited financial results for the year ended December 31, 2016. AWS will be initiating a research report on Shire in the coming days.

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Vas Narasimhan, Global Head Drug Development and Chief Medical Officer at Novartis stated:

"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."

ASCEND-4 Trial

The NDA submission for first-line use of Zykadia was based on the primary analysis of ASCEND-4, a global Phase-III, randomized, open-label, multicenter clinical trial which evaluated safety and efficacy of Zykadia compared to platinum-based chemotherapy, including maintenance, in adult patients with Stage-IIIB or IV ALK+ NSCLC who received no prior therapy for their advanced disease. The study was conducted at 134 clinical trial sites across 28 countries, and randomized across 376 patients. Patients received Zykadia orally at 750 mg/daily or standard pemetrexed-based platinum doublet chemotherapy per label for 4 cycles followed by pemetrexed maintenance.

In the official press release Novartis stated that out of 376 patients, 189 (59 with brain metastases) were randomized to Zykadia and 187 (62 with brain metastases) to chemotherapy. Approximately 60% of patients with baseline brain metastases treated with Zykadia did not have prior radiation therapy. Among patients randomized to the chemotherapy arm, 105 of 145 received an ALK inhibitor as their first treatment after discontinuation of chemotherapy.

The study found that Patients treated with first-line Zykadia had a median progression-free survival (PFS) of 16.6 months compared to 8.1 months for patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance. A 45% risk reduction in PFS was obtained in the Zykadia arm compared to the chemotherapy arm.

In a pre-specified analysis of patients receiving Zykadia without brain metastases at screening, patients experienced a median PFS of 26.3 months compared with 8.3 months among patients treated with chemotherapy.

In a pre-specified analysis of patients receiving Zykadia with brain metastases at baseline, the median PFS was 10.7 months (in the Zykadia group versus 6.7 months in the chemotherapy group. Intracranial overall response rate (ORR) was consistent with whole body ORR.

What is Priority Review and Breakthrough Therapy Designation?

FDA grants Priority Review to applications for drugs that treat serious conditions and, if approved, would provide a significant improvement in treatment safety or efficacy. For applications granted priority review, FDA is to take action within 6 months of submission instead of 10 months under standard review timelines.

Breakthrough Therapy designation is intended to expedite the development and review of drugs that treat serious or life-threatening conditions if the therapy has demonstrated substantial improvement on at least one clinically significant endpoint over an available therapy.

Novartis has received 13 Breakthrough Therapy designations to date; the latest designation is for the first-line treatment of patients with ALK+ NSCLC with brain metastases and is the second Breakthrough Therapy designation for Zykadia.

About Zykadia

Zykadia is an oral, selective inhibitor of anaplastic lymphoma kinase (ALK), a gene that can fuse with others to form an abnormal "fusion protein" that promotes the development and growth of certain tumors in cancers including non-small cell lung cancer (NSCLC). Zykadia was one of the first medicines to be approved following FDA Breakthrough Therapy designation. Zykadia is currently indicated for the treatment of patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to crizotinib. This indication was approved under accelerated approval based on tumor response rate and duration of response. Zykadia is currently approved in over 64 countries worldwide.

Stock Performance

At the closing bell, on Thursday, February 23, 2017, Novartis' stock was slightly up 0.78%, ending the trading session at $77.45. A total volume of 3.53 million shares were traded at the end of the day, which was higher than the 3-month average volume of 3.36 million shares. In the last month and previous three months, shares of the Company have advanced 10.60% and 10.44%, respectively. Moreover, the stock gained 6.33% since the start of the year. The stock is trading at a PE ratio of 27.68 and has a dividend yield of 3.55%.

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SOURCE: Active Wall Street