Breakthrough in treatment approach showing promise in the …
Jan 16, 2025 · Short-course hypofractionated proton beam therapy incorporating advanced imaging may improve overall survival over standard radiation therapy in people over 65 with grade 4 malignant glioblastoma. ... News, information and stories from Mayo Clinic’s cancer experts and patients Breakthrough in treatment approach showing promise in the fight ...
Trial of cell-based therapy for high-risk lymphoma leads to FDA ...
Jul 9, 2024 · In September 2022, the FDA designated CD22-targeting CAR-T therapy for large B-cell lymphoma a Breakthrough Therapy, a move that is meant to speed the development and review of particularly promising drugs that may provide a substantial improvement over existing therapies for serious conditions.
U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy ...
Dec 17, 2024 · FOSTER CITY, Calif.-- (BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy ® (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung …
Breakthrough Therapy Obliterates Deadly Brain Tumor in Days
Mar 15, 2024 · Brain scans of a 72-year-old man diagnosed with a highly aggressive form of cancer known as a glioblastoma have revealed a remarkable regression in his tumor's size within days of receiving an infusion of an innovative new treatment.
FDA Grants Breakthrough Therapy Designation to Seres …
Dec 9, 2024 · “We are thrilled that the FDA has granted Breakthrough Therapy designation to SER-155, underscoring the strength of our Phase 1b clinical data and the potential of this live biotherapeutic candidate to address one of the most significant complications faced by patients undergoing allo-HSCT.
FDA Grants Breakthrough Therapy Designation to Trodelvy for …
Dec 23, 2024 · The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Trodelvy(sacituzumab govitecan-hziy) for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy treatment.
FDA Grants Breakthrough Therapy Designation to Sac-TMT for …
Dec 5, 2024 · Sacituzumab tirumotecan targets TROP2 and is being developed for EGFR-mutated NSCLC after TKI and chemotherapy failure. The FDA's breakthrough therapy designation is based on phase 2 data, highlighting sac-TMT's potential in NSCLC treatment.
Breakthrough Therapy Approvals | FDA
Oct 21, 2024 · The CDER Breakthrough Therapy (BT) Approvals reports contain a list of approvals for breakthrough therapy designated drugs. New reports will be published quarterly for the current calendar...
FDA grants tolebrutinib breakthrough therapy designation in SPMS
Dec 17, 2024 · The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Sanofi’s BTK inhibitor candidate tolebrutinib for the treatment of adults with nonrelapsing secondary...
Brelovitug Granted Breakthrough Designation for Chronic …
4 days ago · The FDA’s Breakthrough Therapy designation for CHD was supported by data from a phase 2 trial evaluating the safety, tolerability, and efficacy of brelovitug in patients with quantifiable ...