FDA approves therapies for colorectal cancer, mantle cell lymphoma
Click Here to Manage Email Alerts
Key takeaways:
- The FDA approved sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer.
- The agency also approved acalabrutinib as part of combination therapy for mantle cell lymphoma.
The FDA approved two oncology regimens on Jan. 16.
One is for a subset of patients with colorectal cancer and the other for treatment of patients with mantle cell lymphoma.
Sotorasib for colorectal cancer
The FDA approved sotorasib (Lumakras, Amgen) with panitumumab (Vectibix, Amgen) as treatment for adults with KRAS G12C-mutated colorectal cancer.
The indication applies to use of the regimen by patients who received previous fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
The agency based approval on results of the randomized CodeBreaK 300, which included 160 patients with KRAS G12C-mutated metastatic colorectal cancer who previously received fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
Researchers randomly assigned patients 1:1:1 to 960 mg oral sotorasib once daily plus 6 mg/kg panitumumab via IV every 2 weeks; 240 mg oral sotorasib 240 mg once daily plus 6 mg/kg panitumumab every 2 weeks; or investigator’s choice of standard of care. Standard care options included regorafenib or trifluridine/tipiracil (Lonsurf; Taiho Oncology, Servier).
PFS per blinded independent central review served as the major efficacy outcome. Secondary outcomes included OS, overall response rate and duration of response.
Results showed a statistically significant PFS improvement among patients assigned the 960 mg sotorasib plus panitumumab compared with those assigned standard care (median, 5.6 months vs. 2 months; HR = 0.48; 95% CI, 0.3-0.78).
A higher percentage of patients assigned the 960 mg sotorasib regimen than standard of care responded to therapy (26% vs. 0%); however, sotorasib-panitumumab did not confer a statistically significant OS benefit compared with standard of care.
The most frequent adverse events reported among patients assigned the 960 mg sotorasib regimen included rash, dry skin, diarrhea, stomatitis, fatigue and musculoskeletal pain.
The most common grade 3/grade 4 laboratory abnormalities included decreased magnesium, decreased potassium, decreased corrected calcium and increased potassium.
In a related action, the FDA approved the therascreen KRAS RGQ PCR Kit (QIAGEN GmbH) as a companion diagnostic device to help determine which patients with colorectal cancer have tumors that harbor KRAS G12C mutations and may be eligible for treatment with the sotorasib-panitumumab combination.
Acalabrutinib for lymphoma
The FDA approved acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults with treatment-naive mantle cell lymphoma who are not eligible for hematopoietic stem cell transplantation.
The agency based approval on results of the randomized ECHO trial, which included 598 patients aged 65 years or older with untreated mantle cell lymphoma who could not receive HSCT.
Researchers randomly assigned patients 1:1 to bendamustine and rituximab plus either acalabrutinib or placebo.
PFS per independent review committee assessment served as the primary endpoint.
After median follow-up of 49.8 months, results showed a statistically significant PFS improvement in the acalabrutinib group (median, 66.4 months vs. 49.6 months; HR = 0.73; 95% CI, 0.57-0.94).
More than two-thirds (69%) of patients assigned acalabrutinib developed serious adverse reactions, the most common of which included pneumonia, COVID-19, pyrexia, second primary malignancy, rash, febrile neutropenia, atrial fibrillation, sepsis and anemia.
Twelve percent of patients assigned acalabrutinib developed fatal adverse reactions.
In a related action, the FDA also granted traditional acalabrutinib monotherapy for adults with previously treated mantle cell lymphoma. The agency had granted accelerated approval for this indication in 2017.
References:
- FDA approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer (press release). Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer. Published Jan. 16, 2025. Accessed Jan. 17, 2025.
- FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma (press release). Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma. Published Jan. 16, 2025. Accessed Jan. 17, 2025.
Read more about
Click Here to Manage Email Alerts