regulatory guidance
EMA's CHMP Recommends Restricting Third-Line Ovarian Cancer Indication for Clovis' Rubraca
The committee said the indication in BRCA1/2-mutated ovarian cancer patients should be removed from the PARP inhibitor label based on negative confirmatory trial data.
Gilead's Tecartus Gets EMA CHMP Recommendation in Advanced ALL
The committee reviewed data showing that 71 percent of patients on the CAR T-cell therapy had a complete remission or complete remission with incomplete hematological recovery.
Bristol Myers Squibb's Opdualag Gets EMA CHMP Recommendation for Biomarker-Selected Melanoma
The committee's recommendation for the immunotherapy combo in tumors expressing PD-L1 in fewer than one percent of cells is more restrictive than FDA's approval.
EMA's CHMP Recommends Novartis' Scemblix for TKI-Intolerant Chronic Myeloid Leukemia Patients
The committee recommended the STAMP inhibitor for previously treated Philadelphia chromosome-positive CML patients based on data from the ASCEMBL trial.
NICE Recommends Eli Lilly's Verzenio as Adjuvant Treatment for High-Risk, Early-Stage Breast Cancer
The agency recommended the CDK4/6 inhibitor plus hormone therapy for HR-positive, HER2-negative, early-stage breast cancer patients at high risk of recurrence.