Leading pharmaceutical company, AstraZeneca, has had to withdraw the anti-cancer drug, vandetanbib (Zactima).
The reasons for Zactima’s withdrawal arise from initial data demonstrating lack of survival advantage during treatment, even when given with chemotherapy. Furthermore, the drug’s ability to relieve patients from relapse post-treatment is no longer satisfactory for authorization.
The drug was meant to block the development of blood supply to cancers, an integral part to progression, by binding to receptors on blood vessels and inhibiting their growth. This would have had a potential impact in the treatment of cancers of the lung and thyroid gland.
Zactima is still undergoing assessment on large patient groups in order to complete the investigation. However, it has been removed from marketing and submission to the European Medicine Agency and The American Food and Drug Administration (FDA).
AstraZeneca now joins others in a disappointing year for cancer drug development. However, with two other drugs being processed down the production line, ZEPHYR and ZETA, there is still potential to turn the table for 2009.
November 23rd, 2009 at 11:04
AZN has not ‘withdrawn’ the drug since it was never given marketing authorization by EMEA or FDA in the first place..
AZN HAS withdrawn it’s regulatory submission of vandetanib for NSCLC. Development of vandetanib in Hereditary Medullary Thyroid cancer is ongoing and in P3 with results expected in early ‘10.
Not really a “wonder drug” either – it has shown inferior PFS/OS to recently rejected Erbitux in NSCLC.
November 23rd, 2009 at 13:27
Point taken
November 23rd, 2009 at 14:40
Development of vandetanib for use in medullary thyroid cancer is not restricted to hereditary MTC. Although patient enrollment in the first phase II study in MTC was restricted to those with hereditary MTC, the current, pivotal study enrolled both hereditary and sporadic MTC.