FDA Approves Four New Oncology Therapies in October 2024
核心洞察
Asciminib (Scemblix) was approved for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (搜索) (CML) based on the ASC4FIRST trial data.
Zolbetuximab-clzb (搜索) (Vyloy) plus chemotherapy gained approval for HER2 (搜索)-negative gastric or gastroesophageal junction adenocarcinoma (搜索) that is CLDN18.2 (搜索)-positive.
Inavolisib (Itovebi) plus palbociclib and fulvestrant was approved for endocrine-resistant, PIK3CA-mutant, HR-positive, HER2 (搜索)-negative advanced breast cancer (搜索).
October 2024 saw the FDA approve four new therapies for various oncology indications, addressing both solid tumors and hematologic malignancies. These approvals span from first-line treatment of chronic myeloid leukemia (搜索) to advanced stages of gastric, breast, and lung cancers, offering new options for patients with significant unmet needs.
Asciminib Approved for Newly Diagnosed CML
The FDA approved asciminib (Scemblix), an oral drug, for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (搜索) (CML) in the chronic phase. The approval was based on the ASC4FIRST trial (NCT04971226), which demonstrated that asciminib outperformed a tyrosine kinase inhibitor (TKI) chosen by the physician in achieving a major molecular response (MMR). Common adverse events associated with asciminib included musculoskeletal pain, rash, fatigue, upper respiratory tract infection, headache, abdominal pain, and diarrhea.
Zolbetuximab-clzb Approved for Gastric and GEJ Adenocarcinoma
Zolbetuximab-clzb (搜索) (Vyloy), in combination with fluoropyrimidine- and platinum-containing chemotherapy, received approval for patients with locally advanced unresectable or metastatic HER2 (搜索)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma that is CLDN18.2 (搜索)-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. Adverse events observed in both trials included vomiting, nausea, pyrexia, pneumonia, diarrhea, and pulmonary embolism.
Inavolisib Approved for Advanced Breast Cancer
Inavolisib (Itovebi), when used in combination with palbociclib (Ibrance) and fulvestrant, was approved for patients with endocrine-resistant, PIK3CA-mutant, hormone-receptor (HR)-positive, HER2 (搜索)-negative locally advanced or metastatic breast cancer (搜索). The FDA's decision was supported by data from the INAVO120 trial (NCT04191499), which demonstrated improved PFS, OS, and duration of response in patients receiving inavolisib plus palbociclib and fulvestrant compared to those receiving placebo plus palbociclib and fulvestrant. Common adverse events occurring in 20% or more of patients treated with inavolisib included decreased neutrophils, decreased hemoglobin, increased fasting glucose, decreased platelets, decreased lymphocytes, stomatitis, diarrhea, fatigue and rash.
Nivolumab Approved for Resectable NSCLC
The FDA approved neoadjuvant nivolumab (Opdivo) plus platinum-doublet chemotherapy, followed by adjuvant nivolumab, for patients with non-small cell lung cancer (搜索) (NSCLC) with no known EGFR (搜索) mutations or ALK (搜索) rearrangements. The approval was based on data from the CHECKMATE-77T trial (NCT04025879), which 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. Adverse events were consistent with those previously observed with nivolumab plus chemotherapy. AEs led to 5.3% of patients in the neoadjuvant nivolumab arm being unable to undergo surgery, compared to 3.5% in the placebo arm. Surgery delays occurred in 4.5% and 3.9% of patients, respectively.