HACKENSACK MERIDIAN HEALTH

FDA Approves Spravato (Esketamine) Nasal Spray as Standalone Treatment for Treatment-Resistant Depression

4 months ago

• The FDA has approved Spravato (esketamine) nasal spray as a monotherapy for adults with treatment-resistant depression (TRD). • Spravato demonstrated rapid and superior improvement in depressive symptoms compared to placebo in clinical trials. • The approval was based on a study where 22.5% of patients achieved remission with Spravato compared to 7.6% with placebo. • Due to risks, Spravato is only available through a restricted program under the supervision of a healthcare provider.

CAN-2409 Viral Immunotherapy Shows Promise in Localized Prostate Cancer

5 months ago

• CAN-2409, combined with valacyclovir and radiation, significantly improved disease-free survival (DFS) in intermediate- to high-risk localized prostate cancer patients. • The Phase 3 PrTK03 trial demonstrated a 30% reduction in disease recurrence or death with CAN-2409 compared to standard of care radiation therapy alone. • Patients treated with CAN-2409 exhibited an 80.4% pathological complete response rate at two years, versus 63.6% in the control group. • Candel Therapeutics plans to engage with the FDA to explore regulatory approval pathways for CAN-2409 in this indication.

Mirvetuximab Soravtansine Gains Global Approvals for FRα-Positive Platinum-Resistant Ovarian Cancer

6 months ago

• Mirvetuximab soravtansine receives European Commission approval for treating FRα-positive, platinum-resistant ovarian cancer after 1-3 prior systemic treatments. • The approval was based on the MIRASOL trial, demonstrating a 35% reduction in disease progression or death risk and a 33% reduction in mortality compared to chemotherapy. • The FDA granted full approval in March 2024, reinforcing mirvetuximab soravtansine's efficacy and superiority over standard care options for advanced ovarian cancer. • Early FRα testing and specialist management of ocular toxicities are crucial for maximizing the efficacy and maintaining the quality of life for patients on mirvetuximab soravtansine.

IDHIFA Clinical Trial Induces Remission in AML Patient with IDH2 Mutation

8 months ago

• A 33-year-old patient with acute myeloid leukemia (AML) achieved remission through a clinical trial using IDHIFA, an oral medication targeting the IDH2 mutation. • The patient, who initially underwent intensive remission induction therapy with chemotherapy, opted for the IDHIFA trial as an alternative to a bone marrow transplant. • IDHIFA works by turning off the mutated IDH2 gene, restoring normal cell function and offering a targeted approach to treating AML in patients with this specific mutation. • The patient experienced minimal side effects and has returned to work and normal activities, highlighting the potential of targeted gene therapy in leukemia treatment.