Last Updated on October 11, 2024 by The Health Master
Gilead Sciences announced that the US Food and Drug Administration (USFDA) has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.
To read more articles on Gilead, click here
The accelerated approval was based on data from the international Phase 2, single-arm TROPHY study.
Of the 112 patients who were evaluable for efficacy, 27.7 per cent of those treated with Trodelvy responded to treatment, with 5.4 per cent experiencing a complete response and 22.3 per cent experiencing a partial response. The median duration of response was 7.2 months (95% CI: 4.7-8.6).
Also read:
NATCO gets tentative USFDA nod for Ibrutinib tablets
First AI device to help detect colon cancer gets USFDA nod
Aleor gets tentative USFDA nod for drug for topical treatment
Zydus Cadila gets final USFDA nod for drug to treat High…
Dr Reddy’s launch generic Sapropterin Dihydrochloride Powder for Oral Solution in…
Camber Pharma Launches Generic Succinylcholine Chloride Inj
Trodelvy’s safety profile in the TROPHY study is consistent with previous observations in metastatic UC and other tumor types.
Among all evaluable treated metastatic UC patients (n=113), the most common (≥25%) adverse reactions were diarrhea (72%), anemia (71%), fatigue (68%), neutropenia (67%), nausea (66%), alopecia (49%), decreased appetite (41%), constipation (34%), vomiting (34%) and abdominal pain (31%).
Adverse reactions leading to treatment discontinuation occurred in 10% of those receiving Trodelvy, with 4% discontinuing treatment due to neutropenia.
“Today’s accelerated approval is thanks to the patients and healthcare professionals involved in the TROPHY study, and we appreciate their partnership,” said Merdad Parsey, Chief Medical Officer, Gilead Sciences.
Also read:
Good storage practice of Medicines at Medical Store
Remdesivir should be supplied only to hospitals: NITI Aayog
Cipla doubles Remdesivir production to meet demand
FICCI recommends PLI-like scheme to ramp-up vaccine production
Black marketing of Remdesivir: DCGI again sounds alert to SLAs
AIOCD asks all its members not to indulge in hoarding of…
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
