In October, several cancer therapies received approval from the Food and Drug Administration in diseases including non-small cell lung cancer, breast cancer, gastric and GEJ adenocarcinoma, acute lymphoblastic leukemia and chronic myeloid leukemia.
Here is a select list of oncology drugs that received FDA approval last month.
Presurgical, Postsurgical Opdivo for Non-Small Cell Lung Cancer
The FDA has granted approval for presurgical Opdivo (nivolumab) plus platinum-doublet chemotherapy, followed by single-agent Opdivo after surgery for patients with resectable tumors measuring at least 4 centimeters and/or node-positive non-small cell lung cancer with no known EGFR mutations or ALK rearrangements.
The CheckMate 77T trial, which the approval was based on, evaluated Opdivo plus chemotherapy before and after surgery for resectable stage 2A to 3B non-small cell lung cancer. Opdivo significantly improved event-free survival compared to chemotherapy alone. While overall survival was not the main focus of the study, the FDA reported no detrimental effect of Opdivo.
Opdivo, according to a news release from manufacturer Bristol Myers Squibb, is the only PD-1 inhibitor shown to demonstrate statistically significant and clinically meaningful benefits in this disease versus chemotherapy in both the presurgical-only setting and as part of a regimen before and after surgery.
Itovebi Combo for Some With Advanced Breast Cancer
Itovebi (inavolisib) plus Ibrance (palbociclib) and Faslodex (fulvestrant) was approved by the FDA for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.
The FDA approved Itovebi based on results from the INAVO120 trial. This trial included 325 patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer. Patients received Itovebi or placebo orally daily with oral Ibrance and Faslodex.
The results 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 for HER2-Negative Gastric or GEJ Adenocarcinoma
Vyloy (zolbetuximab-clzb) with fluoropyrimidine- and platinum-containing chemotherapy was approved by the FDA 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 agency has announced.
The efficacy of Vyloy was shown in the SPOTLIGHT and GLOW clinical trials of patients with CLDN18.2-positive advanced unresectable (not surgically removable) or metastatic (spread from its original site to another part of the body) HER2-negative gastric or GEJ adenocarcinoma. Both trials demonstrated improved progression-free survival and overall survival with the Vyloy regimen compared with placebo.
Jylamvo for Children With Acute Lymphoblastic Leukemia
The FDA expanded its approval of Jylamvo (methotrexate) to include children with acute lymphoblastic leukemia, marking it as the only oral liquid formulation of methotrexate for both adults and children, according to a press release from Shorla Oncology, the drug’s manufacturer.
Jylamvo was originally approved in November 2022 for adults with acute lymphoblastic leukemia in conjunction with a combination chemotherapy maintenance regimen, adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or with a combination chemotherapy regimen, adults with relapsed/refractory non-Hodgkin lymphoma as part of a metronomic combination chemotherapy regimen and some autoimmune diseases, according to Jylamvo’s prescribing information on the FDA’s website.
Scemblix for Some With Newly Diagnosed Chronic Myeloid Leukemia
Scemblix (asciminib) received accelerated approval from the FDA for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
The approval, according to a notice from the FDA, was based on efficacy data from the ASC4FIRST trial, which included 405 patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
The rate of major molecular response at 48 weeks in the study was 68% in patients assigned Scemblix compared with 49% in those assigned the tyrosine kinase inhibitor, with a difference of 19%. When assessing this rate 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%.
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