In recent developments within the field of oncology, several new treatment options have received approval, offering fresh hope for patients battling various forms of cancer. These approvals highlight the advancements in targeted therapies and the ongoing commitment to improving cancer care.
Swissmedic Approvals: Enzalutamide and Trametinib Combinations
The Swissmedic has approved enzalutamide in combination with LHRH agonists for adults with non-metastatic hormone-sensitive prostate cancer and biochemical recurrence who are at high risk of metastasis. This approval is particularly pertinent for patients with a PSA doubling time of ≤ 9 months and who are ineligible for salvage radiotherapy.
Additionally, the Swissmedic has approved the combination of trametinib and dabrafenib for adult patients with unresectable or metastatic solid tumors harboring a BRAF V600E mutation. This treatment is intended for patients whose cancer has progressed after previous treatments and for whom no satisfactory alternative options are available. This approval underscores the importance of personalized medicine in treating complex cancers.
FDA Accelerated Approval: Adagrasib Plus Cetuximab for Colorectal Cancer
The Food and Drug Administration (FDA) has granted accelerated approval to adagrasib in combination with cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC). This approval is based on the promising results from the KRYSTAL-1 trial.
The KRYSTAL-1 trial was a multicenter, single-arm expansion cohort study evaluating the efficacy of adagrasib plus cetuximab in patients with KRAS G12C-mutated CRC who had previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, and a VEGF inhibitor. The trial’s major efficacy outcomes were confirmed overall response rate (ORR) and duration of response (DOR) assessed by blinded independent central review.
In the trial, 94 patients were treated with adagrasib 600 mg twice daily plus cetuximab. The ORR was 34%, with all responses being partial responses. The median DOR was 5.8 months, with 31% of responding patients experiencing a DOR of at least 6 months.
However, the treatment is not without its challenges. The most common adverse reactions (≥20%) reported were rash, nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, headache, dry skin, abdominal pain, decreased appetite, edema, anemia, cough, dizziness, constipation, and peripheral neuropathy. These side effects highlight the need for careful patient management and monitoring during treatment.
These approvals by Swissmedic and the FDA offer new hope and potentially improved outcomes for patients who previously had limited options. As the field of oncology continues to evolve, these advancements underscore the critical role of targeted therapies and personalized medicine in the fight against cancer.
References:
- compendium.ch
- https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-cetuximab-kras-g12c-mutated-colorectal-cancer
Viktor Grünwald
