The Covid-19 pandemic is a particular threat to launches of new drugs by relatively small companies, so when approval comes weeks earlier than expected the problem is maximised. Not so for Immunomedics, which yesterday insisted that it was all set to launch Trodelvy thanks to early investment in remote detailing and virtual video conferencing technology to target top-tier doctors, and hiring telesales staff for lower-tier prescribers. The antibody-drug conjugate, containing the active ingredient sacituzumab govitecan, had suffered protracted delays over manufacturing, but yesterday’s US approval for third-line triple-negative breast cancer came well before its June 2 Pdufa date. The accelerated nod is to be confirmed by the Ascent study, which was halted early for efficacy this month and is to be toplined in mid-2020. Apart from being launched during a pandemic, which Immunomedics admits is “not ideal”, Trodelvy’s biggest problem is a black box warning of neutropenia and diarrhoea. The company says these manageable problems are due to the drug’s SN-38 payload, an irinotecan metabolite. Analyst expect the approval to serve as a springboard into earlier likes of therapy and other cancers; it could also invigorate other projects that, like Trodelvy, target the Trop2 antigen.
|Selected industry assets targeting Trop2|
|Trodelvy (sacituzumab govitecan)||Immunomedics||Anti-Trop2 ADC||Approved for 3L TNBC|
|SKB264||Kelun Group||Anti-Trop2 bispecific MAb||Phase 1|
|DS-1062||Daiichi Sankyo||Anti-Trop2 ADC||Phase 1|
|BAT8003||Bio-Thera Solutions||Anti-Trop2 MAb||Phase 1|
|(E1)-3s||Immunomedics||Anti-Trop2 bispecific MAb||Preclinical|