Gilead's first TROP-2 target drug Trodelvy enters EU review

Gilead recently announced that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for the targeted anticancer drug Trodelvy (sacituzumab govitecan-hziy, SG), which is used for treatment: previously accepted At least two therapies, at least one of which treats unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) adult patients with locally advanced or metastatic disease.

Trodelvy is a first-of-its-kind therapy targeting Trop-2.

Based on the positive results of the Phase 3 ASCENT clinical trial, EMA granted an accelerated evaluation of MAA.

Trodelvy is a new and first-of-its-kind antibody-conjugated drug (ADC) targeting TROP-2.

In April 2019, Everest Medicines and Immunomedics signed an agreement to obtain the rights and interests of Trodelvy in Greater China, South Korea, Mongolia, and Southeast Asian countries and regions.

The active pharmaceutical ingredient of Trodelvy is sacituzumab govitecan, which is formed by coupling a humanized IgG1 antibody targeting the TROP-2 antigen and the metabolically active product SN-38 of the chemotherapy drug irinotecan (a topoisomerase I inhibitor) , The drug-antibody ratio is as high as 7.

In April 2020, Trodelvy received accelerated approval from the US FDA for use in adult patients with mTNBC who have previously received at least two therapies for the treatment of metastatic disease.

Based on the overall efficacy and safety results of Trodelvy in the Phase 3 ASCENT trial, Gilead submitted a supplementary biologics license application (sBLA) to the US FDA, aiming to transform Trodelvy's treatment of mTNBC indications from accelerated approval to full approval.

ASCENT (NCT02574455) is an international, open-label Phase III study that enrolled more than 500 mTNBC patients who had previously received at least two therapies for metastatic disease.

Data released in July 2020 showed that the study reached the primary and key secondary endpoints: the Trodelvy group had a statistically significant improvement in PFS compared with the chemotherapy group (median PFS: 5.

An exploratory analysis published in December 2020 showed that, regardless of the expression of Trop-2, Trodelvy can induce clinical benefit compared with chemotherapy; however, in patients with a medium or high Trop-2 score, Trodelvy observed more Great treatment benefit.

In addition, regardless of the germline BRCA1/2 mutation status, Trodelvy performed better than chemotherapy.

Breast cancer is the most common type of cancer among women, with more than 2 million cases diagnosed globally each year.

In terms of TNBC treatment, in March 2019, Roche’s PD-L1 tumor immunotherapy Tecentriq (Taishengqi, generic name: atezolizumab, atezolizumab) was approved by the US FDA, combined with chemotherapy (Abraxane) for the first-line treatment of PD-L1 positive Patients with locally advanced or metastatic triple-negative breast cancer (TNBC).

In November 2020, Merck’s Keytruda (generic name: pembrolizumab, pembrolizumab) was approved by the U.

Original Source: European Medicines Agency Validates Marketing Authorization application for Sacituzumab Govitecan-Hziy for the Treatment of Metastatic Triple-Negative Breast Cancer