October 2024 FDA Approvals for Oncology
Here’s a roundup of FDA approvals in the oncology space from October 2024.
The FDA approved multiple new cancer therapies in October 2024.
October 2024 brought 4 new FDA drug approvals in the oncology space.
With new drug regimens in both the solid tumor and blood cancer space, it is essential that oncology nurses and advanced practice providers stay up to date on the latest regimens, and know what to expect as far as treatment-emergent adverse events (AEs).
Here is a roundup of cancer-related FDA approvals from the last month.
Asciminib for Ph-Positive CML
The FDA approved the oral drug, asciminib (Scemblix), for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase after data from the ASC4FIRST trial (NCT04971226) showed that the agent outperformed a TKI of physician’s choice when it came to major molecular response (MMR).
Asciminib-related AEs included musculoskeletal pain, rash, fatigue, upper respiratory tract infection, headache, abdominal pain, and diarrhea.1
Zolbetuximab Regimen for Locally Advanced, Unresectable Gastric or GEJ Adenocarcinoma
Frontline zolbetuximab-clzb (Vyloy) plus fluoropyrimidine- and platinum-containing chemotherapy gained approval for patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma that is CLDN18.2-positive. The phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials showed that the zolbetuximab regimen improved progression-free survival (PFS) and overall survival (OS) compared with standard of care.
AEs were similar in both trials, with some of the most common being vomiting, nausea, pyrexia, pneumonia, diarrhea, and pulmonary embolism.2
Inavolisib Combination for PIK3CA-Mutant HR-Positive, HER2-Negative Breast Cancer
Inavolisib (Itovebi) plus palbociclib (Ibrance) and fulvestrant was approved for patients with endocrine-resistant, PIK3CA-mutant, hormone-receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer. Data from the INAVO120 trial (NCT04191499) supported the FDA’s decision, which showed that PFS, OS, and duration of response was better in the group of patients that received inavolisib plus palbociclib and fulvestrant compared to those who received a placebo plus palbociclib and fulvestrant.
Common AEs from the regimen that occurred in 20% or more of patients treated with inavolisib were: decreased neutrophils, decreased hemoglobin, increased fasting glucose, decreased platelets, decreased lymphocytes, stomatitis, diarrhea, decreased calcium, fatigue, decreased potassium, increased creatinine, increased ALT, nausea, decreased sodium, decreased magnesium, rash, decreased appetite, COVID-19 infection, and headache.3
Perioperative Nivolumab Regimen for Non-Small Cell Lung Cancer
The FDA approved neoadjuvant nivolumab (Opdivo) plus platinum-doublet chemotherapy, followed by adjuvant nivolumab for patients with non-small cell lung cancer (NSCLC) with no known EGFR mutations or ALK rearrangements. The agency’s decision came after data from the CHECKMATE-77T trial (NCT04025879) showed that event-free survival (EFS) was not reached in the nivolumab group, whereas it was 18.4 months in the group that received placebo plus chemotherapy, followed by surgery and adjuvant placebo.
AEs were similar to what has previously been seen with nivolumab plus chemotherapy. Among those who underwent neoadjuvant nivolumab, 5.3% were unable to undergo surgery due to AEs, compared with 3.5% in the placebo arm. Also, a total of 4.5% of patients who had neoadjuvant nivolumab experienced surgery delays, compared with 3.9% in the placebo group.4
References
1. FDA. FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukemia. October 29, 2024. Accessed October 29, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-asciminib-newly-diagnosed-chronic-myeloid-leukemia
2. FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma. FDA. Oct. 18, 2024. Accessed Oct. 18, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zolbetuximab-clzb-chemotherapy-gastric-or-gastroesophageal-junction-adenocarcinoma?utm_medium=email&utm_source=govdelivery
3. FDA news release. FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer. October 10, 2024. Accessed October 10, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-inavolisib-palbociclib-and-fulvestrant-endocrine-resistant-pik3ca-mutated-hr-positive
4. FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer. News release. FDA. October 3, 2024. Accessed October 3, 2024. https://tinyurl.com/5475fws4
