Application Made to FDA for Approval of Zactima (vandetanib)

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http://www.medicalnewstoday.com/articles/159402.php

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AstraZeneca (NYSE: AZN) announced the company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for an investigational drug, vandetanib 100 mg for use in combination with chemotherapy for the treatment of advanced non-small cell lung cancer in patients previously treated with one prior anti-cancer therapy. The U.S. and European submissions are supported by data from Phase III clinical studies evaluating the safety and efficacy of vandetanib 100 mg in combination with chemotherapy. Pending approval, the treatment will be marketed as ZACTIMA.

Evaluation of vandetanib is ongoing, as monotherapy or in combination with other anti-cancer therapies in a range of tumour types, including thyroid cancer. Results from the ZEPHYR (300mg monotherapy study in EGFR failures in advanced NSCLC, Phase III) and ZETA (300 mg monotherapy in advanced medullary thyroid cancer, Phase III) studies will be presented in the first half of 2010.

Howard Hutchinson, MD, Chief Medical Officer at AstraZeneca said, "Lung cancer is an area of high unmet need and these submissions are an important step toward potentially broadening the treatment options available for patients."

About Vandetanib

Vandetanib has a unique profile that fights cancer through two clinically proven mechanisms -- by blocking the development of tumour blood supply (anti-angiogenesis or anti-VEGFR), and by blocking the growth and survival of the tumour itself (anti-EGFR). Vandetanib also inhibits RET-tyrosine kinase activity, an important growth driver in certain types of thyroid cancer.

About Vandetanib Phase III Studies

ZODIAC (ZACTIMA in cOmbination with Docetaxel In non-smAll cell lung Cancer) is a Phase III randomised, double-blind, placebo-controlled study evaluating the combination of vandetanib 100mg once daily plus docetaxel versus docetaxel alone in patients with locally advanced or metastatic NSCLC, treated with one prior anti-cancer therapy. It enrolled 1391 patients at 250 centres throughout Europe, North America, South America and Asia Pacific.

ZEAL (ZACTIMA Efficacy with Alimta in Lung cancer) is a randomised, double-blind, placebo-controlled Phase III study evaluating the combination of vandetanib 100mg with pemetrexed versus pemetrexed alone in patients with locally advanced or metastatic NSCLC, treated with one prior anti-cancer therapy. It enrolled 534 patients at 160 centres across 23 countries.

ZEST (ZACTIMA Efficacy Study versus Tarceva) is a Phase III randomised, double-blind, multi-centre study to assess the efficacy of vandetanib 300mg versus erlotinib in patients with locally advanced or metastatic NSCLC after failure of at least one prior anti-cancer therapy. It enrolled 1240 patients at 171 centres across 22 countries.

ZEPHYR (ZACTIMA Efficacy trial for NSCLC Patients with HistorY of EGFR-TKI and chemo-Resistance) is a Phase III, randomised, double-blind, parallel-group, multi-centre study evaluating the efficacy of ZACTIMA 300mg plus best supportive care versus best supportive care in patients with locally advanced or metastatic (stage IIIB-IV) NSCLC after prior therapy with an EGFR inhibitor. The study is running in approximately 170 centres across 23 countries.

ZETA (Zactima Efficacy in Thyroid Cancer Assessment) is a phase III, randomized, double-blind, placebo-controlled, multi-centre study, evaluating once-daily ZACTIMA 300mg as a monotherapy in advanced medullary thyroid cancer.

About lung cancer

-- Over 1.35 million new cases of lung cancer are diagnosed every year and nearly 1.2 million people die as a result of this devastating disease -- more than breast, colon and prostate cancer combined(i)

-- Non-small cell lung cancer accounts for around 85% of all lung cancers(ii)

-- If lung cancer is detected at early stages, before it has spread to other organs or lymph nodes, around half of patients can survive for five years or more. However, few lung cancers are found at this early stage and it is normally diagnosed at the advanced stage, when five year survival falls to approximately 15%(iii)

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(Medical News Today, Regulatory Affairs / Drug Approvals; Clinical Trials / Drug Trials; Pharma Industry / Biotech Industry, July 31, 2009)

Disclaimer:

The information contained in these articles may or may not be in agreement with my own opinions. They are not being posted with the intention of being medical advice of any kind.