Steba’s Tookad: US FDA Panel To Weigh Novel Endpoints, Missing Data And Toxicities
Sponsor seeks accelerated approval for low-risk, early-stage prostate cancer based on a trial that met its coprimary endpoints, but agency says interpretation of those results is complicated by novelty of the outcomes, data quality issues and increase in genitourinary adverse events.
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Lilly’s Cyramza Wins Slim Nod, But Steba’s Tookad Falls Hard At US FDA Panel
Oncologic Drugs Advisory Committee votes 6-5 that ramucirumab’s benefit/risk profile is favorable in first-line lung cancer, but 13-2 that pivotal trial data do not support approval of Steba’s vascular-targeted, photodynamic therapy for low-risk prostate cancer.
Expanded Lung Cancer Claim For Lilly’s Cyramza Faces US FDA Scrutiny
Oncologic Drugs Advisory Committee will consider whether a statistically significant benefit on progression-free survival, but no survival advantage, is enough to secure a first-line lung cancer indication for ramucirumab.
28 New Drug Approvals In EU: Cancer Dominates, But RA, Skin & Blood Disorders Well Served Too
Twenty-eight new products containing a total of 29 new active substances were authorized for marketing in the EU in 2017, very much line with the 2016 tally. As in that year, oncology dominated the 2017 approvals, which also included new drugs for rheumatoid arthritis, skin & blood disorders, and hepatitis C.