Yervoy Approval Has Shifted Development Landscape For Melanoma
With Bristol-Myers Squibb Co.’s ipilimumab cleared and Roche/Daiichi Sankyo’s BRAF inhibitor vemurafenib (RG7204) on track for a filing and perhaps approval this year, companies developing other melanoma drugs face a more complicated, competitive path to market.
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Cancer Immunotherapies Have FDA, Industry Looking For New Endpoints
Modifying existing tumor response criteria or developing novel intermediate endpoints could address shortfalls in immuno-oncology efficacy assessments with traditional endpoints such as overall response rate and progression-free survival.
Amgen’s Imlygic Approval A Milestone For Oncolytic Cancer Vaccines
Company prices Imlygic (T-VEC) cancer vaccine at the average cost of $65,000, aims to launch within a week.
Merck’s Keytruda Opens Door, But Combination Trials Could Unlock Efficacy
FDA’s approval of Merck’s anti-PD-1 drug pembrolizumab in melanoma marks a major milestone for oncology and industry’s immune checkpoint efforts. But with an overall response rate in labeling of 24%, there’s still room for improvement with combinations and use in earlier lines of therapy.