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Cancer Approvals From November You Might Have Missed


The Food and Drug Administration approved six new cancer therapies in November 2023.

image of FDA logo

The Food and Drug Administration (FDA) has been exceptionally busy in November 2023, approving six new treatments in the oncology space — and CURE® covered them all.

In case you missed it, here is a list of the new therapies that were making headlines this month.

Xtandi for High-Risk Prostate Cancer

Xtandi (enzalutamide) was approved for patients with non-metastatic castration-resistant prostate cancer that is at a high risk for biochemical recurrence (recurrence indicated by a rising prostate-specific antigen level). Of note, this was the first time a drug of this kind — an androgen receptor signaling inhibitor — was approved for this patient population.

The approval was based off of findings from the phase 3 EMBARK trial, which showed that Xtandi plus leuprolide improved five-year metastases-free survival compared to leuprolide only, at 87.3% and 71.4%, respectively.

Truqap Plus Chemo for Some Patients With HR-Positive, HER2-Negative Breast Cancer

The FDA also approved Truqap (capivasertib) in combination with the chemotherapy agent, fulvestrant, for adults with HR-positive, HER2-negative, locally advanced or metastatic breast cancer who previously received at least one PIK3CA/AKT1/PTEN-alteration and who have progressed on at least one endocrine-based regimen in the metastatic setting or recurrence at or within one year of completing adjuvant therapy. The agency also approved a companion diagnostic to determine which patients are eligible for treatment with Truqap.

Findings from the CAPItello-291 trial, which showed that Truqap plus chemotherapy improved progression-free survival (time from treatment until death or disease worsening) over placebo and chemotherapy, led to the Nov. 16 approval. Median progression-free survival was twice as long in the Truqap group than in the placebo group, at 7.3 and 3.1 months, respectively.

Keytruda Plus Chemo for Advanced HER2-Negative Gastric, GEJ Cancers

The combination of Keytruda (pembrolizumab) plus certain types of chemotherapies gained FDA approval for the treatment of patients with advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, after findings from the KEYNOTE-859 clinical trial showed that overall survival (time from treatment until death of any cause) was better with the Keytruda-chemotherapy combination than it was with the placebo-chemotherapy combination.

Specifically, median overall survival was 12.9 months in the Keytruda group and 11.5 months in the placebo group. Additionally, progression-free survival was 6.9 months and 5.6 months in the Keytruda and placebo groups, respectively.

Keytruda is an immunotherapy agent that works by blocking certain proteins that allow cancer cells to hide from the immune system.

Augtyro for Patients With NSCLC Subset

Also this month, the FDA approved a new drug, Augtyro (repotrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung cancer. ROS1 is a gene fusion that could, according to the American Lung Association, cause uncontrolled cancer cell growth. Augtyro works by targeting ROS1.

Findings from the TRIDENT-1 trial, which backed the recent FDA approval, showed that 79% of patients experienced responses from the treatment, with 6% experiencing complete responses, meaning that their disease completely disappeared. For patients who were previously treated with a ROS1 tyrosine kinase inhibitor but not chemotherapy, the response rate was 38%.

Fruzaqla for Previously Treated Metastatic Colorectal Cancer

The FDA approved an oral targeted therapy, Fruzaqla (frutquitinib), for patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy as well as an anti-VEGF therapy, and if their disease RAS wild-type and medically appropriate, an anti-EGFR therapy.

Two clinical trials, FRESCO-2 and FRESCO, led to the drug’s approval. FRESCO-2 found that the median overall survival of patients treated with Fruzaqla was 7.4 months compared with 4.8 months following treatment with placebo. Meanwhile, in FRESCO, Fruzaqla led to a median overall survival of 9.3 months versus 6.6 months for patients treated with placebo.

Keytruda Plus Chemo for Locally Advanced, Metastatic Biliary Tract Cancer

The first FDA approval of the month was Keytruda plus chemotherapy drugs — gemcitabine and cisplatin, to be exact — for locally advanced unresectable or metastatic biliary tract cancer.

Data from the phase 3 KEYNOTE-966 trial supported the FDA’s decision. Study findings showed that median overall survival was 12.7 months in the Keytruda-chemotherapy group, compared with 10.9 months in the group that received placebo plus chemotherapy. Further, adding the immunotherapy agent to chemotherapy reduced the risk of death by 17%.

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