No added benefit for vandetanib/“Caprelsa“

19.06.2012 09:40

In a recently published report on early benefit assessment, the Institute for Quality and Efficiency in Health Care (IQWiG) found no evidence of added benefit for the drug "Caprelsa" (active ingredient: vandetanib) in the treatment of patients with medullary thyroid carcinoma (MTC). "The manufacturer failed to submit any data on patient-relevant endpoints in its dossier for the patients for whom the drug is approved," the institute concluded. Given these deficiencies, IQWiG felt compelled to declare the dossier "incomplete in content.".

In the registration study, vandetanib had shown a statistically significant advantage over placebo for the endpoints "progression-free survival (PFS)", "objective response rate (ORR)" and "time to pain progression (TWP)", but the IQWiG classified these as non-patient-relevant endpoints.
AstraZeneca, on the other hand, emphasizes that it provided the complete data from the vandetanib approval study in its dossier. However, the institute refrained from analyzing and evaluating this data because the patient population covered by the drug's approval was not sufficiently clearly defined from the overall study population for this very rare disease. "The fact that differing views on defining a study population already lead to the product's failure in the IQWiG assessment ultimately helps no one," explains Dr. Kai Richter, Medical Director of AstraZeneca Germany.