At its April 2024 meeting, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) made recommendations for Fruzaqla, Truqap, and Eribulin Baxter for the treatment of specific cancers.
Fruzaqla for Metastatic Colorectal Cancer
A positive opinion was adopted for fruquintinib (Fruzaqla), which is indicated for the treatment of patients with previously treated metastatic colorectal cancer.
Among new colorectal cancer diagnoses, 20% of patients have metastatic disease at presentation and another 25% who present with localized disease will later develop metastases.
Fruquintinib is a kinase inhibitor that works on the principle of inhibiting tumor angiogenesis. As a selective oral inhibitor of VEGFR-1, -2, and -3, the drug effectively blocks the pathways that facilitate blood vessel formation in tumors.
Results of the FRESCO-2 trial found that treatment with fruquintinib resulted in a significant and clinically meaningful benefit in overall survival compared with placebo in patients with refractory metastatic colorectal cancer — median overall survival was 7.4 months in the treatment group vs 4.8 months in the placebo group. The study's authors wrote that the data supported the use of fruquintinib as a global treatment option for patients with refractory metastatic colorectal cancer.
Truqap for Breast Cancer
The CHMP gave a positive opinion forcapivasertib (Truqap) for the treatment of locally advanced or metastatic breast cancer with one or more specific genetic mutations: PIK3CA, AKT1, or PTEN.
Capivasertib is an AKT inhibitor that targets the cancer-driving protein molecule AKT — also known as protein kinase B or PKB. It locks into a cavity in the target protein, like a molecular key, to block the protein's cancer-driving activity. It is taken orally and is used in combination with fulvestrant.
The CAPtello-291 trial found that capivasertib-fulvestrant therapy resulted in significantly longer progression-free survival than did treatment with fulvestrant alone among patients with hormone receptor–positive advanced breast cancer whose disease had progressed during or after previous aromatase inhibitor therapy with or without a CDK4/6 inhibitor. In the overall population, the median progression-free survival was 7.2 months in the capivasertib-fulvestrant group, compared with 3.6 months in the placebo-fulvestrant group.
Eribulin Baxter for Breast Cancer and Liposarcoma
A positive opinion was adopted for eribulin (Eribulin Baxter), a generic of Halaven (by Japanese pharmaceutical company Eisai). The drug is indicated for the treatment of adults with locally advanced or metastatic breast cancer, and adults with unresectable, advanced, or metastatic liposarcoma.
Eribulin is an antineoplastic agent that inhibits the growth phase of microtubules without affecting the shortening phase. It also sequesters tubulin into nonproductive aggregates, preventing microtubule assembly. By disrupting mitotic spindles, eribulin blocks the cell cycle leading to apoptotic cell death.
Halaven has been authorized in the European Union since March 17, 2011. Because eribulin is administered intravenously and is 100% bioavailable, a bioequivalence study vs the reference product Halaven was not required, explained the EMA.