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Fly News Breaks for December 20, 2016
AZN, CLVS, TSRO
Dec 20, 2016 | 07:54 EDT
Commenting on Clovis' (CLVS) Rubraca accelerated approval by the FDA for the treatment of germline or somatic BRCA-mutated ovarian cancer patients, Leerink analyst Seamus Fernandez says the label appears "fairly broad" and does not restrict use based on platinum sensitivity/resistance. While he believes this current approval is unlikely to impact the initial competitive dynamics for TESARO's (TSRO) niraparib or AstraZeneca's (AZN) Lynparza in second-line maintenance, the analyst points out that data from Rubraca's Phase 3 ARIEL3 trial in this setting is now expected in mid-2017. Despite the earlier readout, Fernandez continues to see niraparib as the ultimate winner in second-line maintenance. He reiterates an Outperform rating on TESARO's shares.