US nod for Opdivo in pre-treated small cell lung cancer
US regulators have further expanded the scope of Bristol Myers Squibb’s Opdivo, approving its use for a previously treated small cell lung cancer.
The immunotherapy is now the first and only immuno-oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.
Clearance for this indication was granted by the US Food and Drug Administration under the regulator’s accelerated approval pathway based on overall response rate (ORR) and duration of response (DOR) data, so continued approval may be contingent upon verification of clinical benefit in confirmatory trials.
Read more: http://www.pharmatimes.com/news/us_nod_for_opdivo_in_pre-treated_small_cell_lung_cancer_1249436
The immunotherapy is now the first and only immuno-oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.
Clearance for this indication was granted by the US Food and Drug Administration under the regulator’s accelerated approval pathway based on overall response rate (ORR) and duration of response (DOR) data, so continued approval may be contingent upon verification of clinical benefit in confirmatory trials.
Read more: http://www.pharmatimes.com/news/us_nod_for_opdivo_in_pre-treated_small_cell_lung_cancer_1249436