According to DelveInsight’s epidemiology model, the total incident cases of ... The recent approvals of PD-1 inhibitors like KEYTRUDA (pembrolizumab) and PARP inhibitors like LYNPARZA (olaparib ...
The company also posted a 6% year-over-year growth in total product sales, driven by an 8% increase in sales of its HIV treatment Biktarvy and a 23% rise for its oncology drug, Trodelvy.
Trodelvy’s withdrawal is one of several conditional approvals that have been rescinded in recent years, most notably among the “PD-1” class of drugs that includes Keytruda and Bristol Myers ...
It takes on average 447 days between Keytruda receiving safety approval for a cancer type and being listed on the Pharmaceutical Benefits Scheme. Manufacturer MSD Australia and New Zealand is ...
Trodelvy’s next big NSCLC readout is EVOKE-03, which is testing the Gilead drug with Merck’s PD-1 inhibitor Keytruda in PD-L1-high NSCLC. Started in February 2023, the trial currently bears a ...
In a phase 3 trial, more deaths due to adverse events were reported in the Trodelvy arm compared with the chemotherapy arm. Gilead has made the decision to withdraw the accelerated approval of ...
AstraZeneca and Amgen's drug could have a new use after positive Phase 3 study results. Elsewhere, Jazz set new plans for a ...
Trodelvy shows consistent efficacy in metastatic triple-negative breast cancer with a 27.8% ORR and 4.8 months PFS. Enhertu demonstrates promising results in HER2-low patients post-Trodelvy, achieving ...
Trodelvy's FDA approval for bladder cancer was rescinded due to unmet survival endpoints in the TROPICS-04 study. The drug remains approved for certain breast cancer treatments, highlighting its ...
But with its cell therapy unit stalling and antibody-drug conjugate Trodelvy facing challenges, the company’s oncology ambitions were brought back under the spotlight during its third-quarter ...
Gilead Sciences plans to voluntarily withdraw U.S. accelerated approval for Trodelvy in metastatic urothelial cancer. The decision followed results from the TROPiCS-04 study, which failed to meet ...