In Europe, two new cancer drugs have been recommended for approval, and one has had its marketing authorization withdrawn.
The opinions were issued by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) at its meeting this week.
New Drug for TNBC
The CHMP recommended the granting of a conditional marketing authorization for sacituzumab govitecan (Trodelvy) for the treatment of unresectable or metastatic triple-negative breast cancer (TNBC).
The drug is a novel antibody-drug conjugate in which SN-38, an active metabolite of the chemotherapy drug irinotecan , is coupled to a monoclonal antibody that targets an antigen that has high expression in TNBC and induces cancer cell growth.
Sacituzumab govitecan was approved by the US Food and Drug Administration (FDA) in April 2021.
In the randomized, phase 3 ASCENT trial of 468 patients, median progression-free survival was 5.6 months in the sacituzumab govitecan-treatment group compared with 1.7 months in the conventional chemotherapy group.
Median overall survival rates were 12.1 months and 6.7 months, respectively (P < .001 for both comparisons), according to results published in the New England Journal of Medicine.
“The benefit with sacituzumab govitecan was seen in all clinical and prespecified subgroups, including patients who received previous treatment with PD-1 or PD-L1 inhibitors,” wrote the research team, led by Aditya Bardia, MD, of the Massachusetts General Hospital Cancer Center in Boston.
The most common side effects are diarrhea, nausea, neutropenia, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, cough, and abdominal pain, according to the EMA.
New Drug for NSCLC With EGFR Exon 20
The CHMP also recommended the granting of a conditional marketing authorization for amivantamab (Rybrevant) for the treatment of non-small cell lung cancer (NSCLC).
Specifically, amivantamab monotherapy is indicated for treatment of advanced NSCLC with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based therapy. This is the first targeted treatment for this subtype of lung cancer.
Amivantamab was approved for this use by the FDA in May 2021.
In a phase 1 clinical trial with 81 patients with NSCLC with EGFR exon 20 insertion mutations, the overall response rate (the primary outcome) with amivantamab was 40%; the median duration of response was 11.1 months. For 63% of patients, the duration of response was 6 months or longer. Median follow-up was 9.7 months.
The most common side effects are rash, infusion-related reactions, nail toxicity, hypoalbuminemia, edema, fatigue, stomatitis, nausea, and constipation, according to the EMA.
Authorization Withdrawn for Anal Cancer Drug
An application for an initial marketing authorization for retifanlimab (Zynyz) in the treatment of squamous carcinoma of anal cancer was withdrawn by Gilead Sciences Ireland.
The EMA said it was not clear whether the number and duration of responses seen with the drug, which is a checkpoint inhibitor, would lead to “meaningful benefits” in terms of overall survival and progression-free survival.
The EMA provided the company with questions about the initial application, but the company did not respond at the time of the withdrawal, the agency said.
In the United States, the agent is pending FDA approval for locally advanced or metastatic squamous cell carcinoma of the anal canal that has progressed on or is intolerant to platinum-based chemotherapy.