FDA Approves Drug for Aggressive Small-Cell Lung Cancer - WebMD
3 days ago · LS-SCLC is an aggressive form of small-cell lung cancer that starts in the main airways of the lungs (bronchi) and is generally limited to one lung or one side of the chest.
Imfinzi (Durvalumab) Now Approved for Limited-Stage Small Cell …
3 days ago · The expanded approval of Imfinzi is the only FDA-approved immunotherapy combination for patients with LS-SCLC and provides a new standard of care for patients with early-stage SCLC. The approval was based on results from the phase 3, double-blind, randomized, placebo-controlled ADRIATIC study which …
FDA approves durvalumab for limited-stage small cell lung cancer
On December 4, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed ...
Imfinzi Approved as Consolidation in LS-SCLC
6 days ago · The trial (NCT03703297) included 730 patients with stage I-III LS-SCLC whose disease had not progressed after concurrent chemoradiation therapy. ... News release. AstraZeneca. December 5, 2024.
Imfinzi Approved for Limited-Stage Small Cell Lung Cancer
2 days ago · The Food and Drug Administration (FDA) has approved Imfinzi ® (durvalumab), as a single agent, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.. The approval was supported by the randomized, double-blind, placebo-controlled phase 3 ADRIATIC study ...
Imfinzi Approved in the US as First and Only Immunotherapy …
Dec 5, 2024 · Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths. 5-6 Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15% of cases classified as SCLC. 7. LS-SCLC (Stage I-III) is classified as SCLC that is generally only in one lung or one ...
FDA OKs Durvalumab in Limited-Stage SCLC
Dec 4, 2024 · The FDA has approved durvalumab (Imfinzi) for patients with limited-stage small cell lung cancer who have not progressed after concurrent platinum-based chemotherapy and radiation therapy, according to a press release from the agency. 1.
Imfinzi Approved for Limited-Stage Small Cell Lung Cancer
Dec 5, 2024 · The Food and Drug Administration (FDA) has approved Imfinzi ® (durvalumab), as a single agent, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose...
Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell …
Sep 13, 2024 · Adjuvant therapy with durvalumab, with or without tremelimumab, may have efficacy in patients with limited-stage small-cell lung cancer who do not have disease progression after standard concurrent...
Imfinzi granted Priority Review and Breakthrough Therapy …
Aug 15, 2024 · The ADRIATIC trial is a randomised, double-blind, placebo-controlled, multi-centre global Phase III trial evaluating Imfinzi monotherapy and Imfinzi plus Imjudo (tremelimumab) versus placebo in the treatment of 730 patients with LS …