The FDA has granted approvals for several oncology drugs in October 2024, targeting a range of cancers including non-small cell lung cancer, breast cancer, gastric cancer, leukemia. These approvals mark significant advancements in treatment options for patients with these diseases.
Opdivo Approved for Resectable Non-Small Cell Lung Cancer
Bristol Myers Squibb's Opdivo (nivolumab), a PD-1 inhibitor, has been approved for use in combination with platinum-doublet chemotherapy before surgery, followed by single-agent Opdivo after surgery, for patients with resectable non-small cell lung cancer (NSCLC) that is at least 4 centimeters in size and/or node-positive, without EGFR mutations or ALK rearrangements. The approval was based on the CheckMate 77T trial, which demonstrated a statistically significant improvement in event-free survival compared to chemotherapy alone. While overall survival was not the primary endpoint, no detrimental effect of Opdivo was observed. Opdivo is the only PD-1 inhibitor to demonstrate statistically significant and clinically meaningful benefits in this setting versus chemotherapy in both the presurgical-only setting and as part of a regimen before and after surgery.
Itovebi Combo Approved for Advanced Breast Cancer
The FDA approved Itovebi (inavolisib) in combination with Ibrance (palbociclib) and Faslodex (fulvestrant) for adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. The approval was based on the INAVO120 trial, which included 325 patients and showed a significant improvement in progression-free survival for patients treated with Itovebi compared to placebo. Additionally, more patients in the Itovebi group experienced tumor shrinkage, and the duration of this response was longer.
Vyloy Approved for HER2-Negative Gastric or GEJ Adenocarcinoma
Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy has been approved for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma with tumors that are CLDN18.2 positive. The efficacy of Vyloy was demonstrated in the SPOTLIGHT and GLOW clinical trials, which showed improved progression-free survival and overall survival with the Vyloy regimen compared with placebo.
Jylamvo Approval Expanded for Children with Acute Lymphoblastic Leukemia
The FDA expanded its approval of Jylamvo (methotrexate) to include children with acute lymphoblastic leukemia, making it the only oral liquid formulation of methotrexate available for both adults and children. Jylamvo was initially approved in November 2022 for various indications, including adults with acute lymphoblastic leukemia.
Scemblix Receives Accelerated Approval for Chronic Myeloid Leukemia
Scemblix (asciminib) received accelerated approval from the FDA for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. The approval was based on efficacy data from the ASC4FIRST trial, which included 405 patients. The rate of major molecular response at 48 weeks was 68% in patients assigned Scemblix compared with 49% in those assigned a tyrosine kinase inhibitor, representing a 19% difference. In the tyrosine kinase inhibitor group particularly in those treated with Gleevec, the rate of major molecular response was 69% in the Scemblix arm compared with 40% in the tyrosine kinase inhibitor arm, with a difference of 30%.
