AstraZeneca's thyroid cancer drug Caprelsa gets positive CHMP opinion
Anglo-Swedish drug major AstraZeneca (LSE: AZN) revealed this morning that its Marketing Authorization Application for Caprelsa (vandetanib) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
The proposed indication also states that for patients in whom Rearranged during Transfection (RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions. Vandetanib was approved by the US Food and Drug Administration and launched in the USA in the spring (The Pharma Letter April 17). Because of the relatively small patient population for MTC, peak sales potential for the drug is put at around $200 million,
Clinical backing
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