- Center on Health Equity and Access
- Clinical
- Health Care Cost
- Health Care Delivery
- Insurance
- Policy
- Technology
- Value-Based Care
Amgen's T-Vec Receives Poor FDA Staff Review
The accelerated review, the results of which were made public 2 days prior to a vote by an FDA advisory panel on using T-Vec in melaonma, cited concerns over the design and results of a key study with the viral drug.
FDA staff reviewers said an accelerated review of drugmaker Amgen Inc's skin cancer immunotherapy cannot be considered at this time, citing concerns over the design and results of a key study.
The reviewers said in documents made public on Monday that it was unclear whether the treatment, a cancer-killing virus called talimogene laherparepvec or "T-Vec", improved overall survival, raising questions over its effectiveness. The review comes two days before a panel of FDA advisers votes on whether T-Vec should be approved to treat melanoma.
The FDA typically accepts the panel's recommendations.
Link to the Reuter's news:
Cellular Therapies in Lymphoma Bring Hope, But Optimizing Their Use Remains a Challenge
December 10th 2023Recent decades have seen marked improvements in hematological cancer outcomes and an expanded armamentarium of therapies, but novel treatments require updated strategies that are not always easy to fine-tune, according to presenters at the 2023 American Society of Hematology Annual Meeting and Exposition.
Read More
California Aims for Equity by Redefining Cancer Care
December 8th 2023Authors highlight key aspects of the California Cancer Care Equity Act, including its focus on Medi-Cal beneficiaries, the requirement for managed care plans to contract with specialized cancer centers, and the definition of complex cancers.
Read More
Dr Kathryn Lindley on Pregnancy-Related Cardiovascular Care Gaps and Training Initiatives
December 8th 2023Cardiologists need skills in risk assessment, contraception counseling, and hypertension management for pregnant patients, according to Kathryn Lindley, MD, FACC, Vanderbilt University Medical Center.
Read More
