Results for 'AA'
Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated
medicare spending, drug indications, AA, FDA, medicare, ODAC
Medicare Parts B and D spent at least $569 million between 2017 and 2019 on 10 cancer drug indications without confirmed overall survival (OS) benefit after accelerated approval (AA). Approximately $224 million was spent on drug indications that were either voluntarily withdrawn or recommended fo…
Oct 18th • 5 mins read
Cancer experts point to new advances in research and treatment: A recent report by the American Association for Cancer Research highlights unprecedented successes as well as ongoing challenges in the cancer field
FDA, AACR, immunotherapeutics, immunotherapy, precision therapies, ALK, EGFR, BRAF
Within the last few years, cancer research has made significant strides, leading to the approval of 22 new cancer treatments by the FDA between August 1, 2017, and July 31, 2018. Among these, notable advancements include 14 anticancer therapeutics, such as CAR T-cell therapies for non-Hodgkin lympho…
Apr 1st • 2 mins read
Accelerated drug approvals in oncology: Pros and cons
Clinical study, drug approval, medical oncology
The summary of the content highlights the success of the accelerated approval process, especially for oncology drugs. Key points include: The rise of accelerated approval processes is significant, particularly in oncology. The use of surrogate endpoints and their validation has been debated. Th…
Sep 14th • 4 mins read
Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval
US, FDA, approval, drugs, benefits, cancer
Among 5 oncology indications, 26.1% of eligible treatment initiations involved an Accelerated Approval (AA) indication that was later withdrawn due to lack of benefit. There is an inherent trade-off between expediting access to promising cancer drugs and the potential withdrawal of some indicatio…
Dec 8th • 2 mins read
Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology Indications Compared With the US Food and Drug Administration Accelerated Approval Program
canada, oncology, malignant, hematology, HTC
Canadian regulatory approvals align with FDA decisions, but submission numbers to Health Canada (HC) and Health Technology Assessment (HTA) processes are lower in Canada. There is a nearly 3-year delay between Accelerated Approval (AA) and funded access to treatment for Canadians. HTA in Canada …
Jun 5th • 6 mins read