The AJMC® Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.
FDA Approves Darolutamide Combo for Metastatic Hormone-Sensitive Prostate CancerAugust 9th 2022
Darolutamide, sold as Nubeqa, is an androgen receptor inhibitor, which works to limit prostate cell growth by preventing the binding of hormones, or androgens, to proteins known as androgen receptors.
Trastuzumab Deruxtecan Wins Rapid Approval for HER2-Low Breast CancerAugust 6th 2022
The approval came exactly 2 months after results from the landmark DESTINY-Breast04 trial showed that the antibody drug conjugate reduced the risk of disease progression or death by 50% compared with chemotherapy for HER2-low patients with both hormone receptor (HR)–positive and HR-negative disease.
Dabrafenib Plus Trametinib Approved as First Tumor-Agnostic Therapy for BRAF V600E–Mutated Solid TumorsJune 22nd 2022
The combination is the first and only therapy to be approved with a tumor-agnostic indication in both children and adults with solid tumors that have a BRAF V600E mutation, Novartis said late Wednesday.
FDA Approves Tisa-Cel for Third Indication, R/R Follicular LymphomaMay 31st 2022
Tisagenlecleucel (tisa-cel) was approved to treat adults with relapsed or refractory (R/R) follicular lymphoma. This is the third indication for the therapy since it became the first FDA-approved chimeric antigen receptor T-cell therapy in 2017.
Nivolumab-Based Combos Approved in First-line Advanced ESCCMay 28th 2022
The approvals were announced by Bristol Myers Squibb (BMS), maker of the 2 immunotherapy treatments approved for 1 combination: nivolumab (Opdivo), the first approved PD-1 immune checkpoint inhibitor, and ipilimumab (Yervoy), which activates the immune system by targeting CTLA-4.
FDA Approves Enhertu for Use in Metastatic Breast CancerMay 5th 2022
This approval of trastuzumab deruxtecan (Enhertu) follows the March release of data from the DESTINY-Breast03 trial on the anti-HER2 monoclonal antibody, also a HER2-directed antibody-drug conjugate, which indicated superior outcomes vs trastuzumab emtansine.
What We’re Reading: Mavacamten Approved for HCM; Oklahoma Abortion Bans; Baby Formula WhistleblowerApril 29th 2022
A new drug has been approved for obstructive hypertrophic cardiomyopathy (HCM); Oklahoma enacts a strict abortion ban; whistleblower claims alarms had been raised about Abbott baby formula contamination.
What We’re Reading: Epilepsy Drug Approval; Free COVID-19 Testing Ends; EPA SuedMarch 28th 2022
The FDA approved a drug to treat a rare form of childhood epilepsy; uninsured Americans will no longer have access to free COVID-19 tests; a conservation group is suing the Environmental Protection Agency (EPA) over failure to protect rivers from pollution.
Olaparib Approval Expands Breast Cancer Treatment OptionsMarch 14th 2022
The FDA based its approval on OlympiA trial data, which show the PARP inhibitor has the ability to reduce risks of invasive breast cancer recurrence, second cancers, and death, and to improve overall survival.
Xipere for Macular Edema Associated With Uveitis Launches in United StatesFebruary 16th 2022
The treatment was approved in October 2021 and is the first FDA-approved therapy to treat macular edema associated with uveitis via injection to the suprachoroidal space, which provides a more targeted delivery mechanism.
FDA Grants Breakthrough Device Designation to Foundation Medicine’s ctDNA TrackerFebruary 15th 2022
Foundation Medicine’s circulating tumor DNA (ctDNA) detection and monitoring assay, FoundationOne Tracker, was granted a Breakthrough Device Designation from the FDA, streamlining the approval and review processes to give patients and providers earlier access to the device.
What We’re Reading: Boosters Slash COVID-19 Deaths; Generic Restasis Cleared; Medicare Advantage and Health EquityFebruary 3rd 2022
Americans who are boosted are 95 times less likely than unvaccinated people to die of COVID-19, the FDA approved the first generic drug for Restasis to treat dry eye syndrome, and CMS is putting a greater focus on health equity for Medicare Advantage and Part D plans.