Eyeing standard of care status in 3rd-line TNBC, Gilead nails down full OK for Trodelvy with a slightly broader label
Even as the FDA gets tough on drugs that miss their mark after accelerated approvals, the agency is still quick to reward the ones that hit it.
Gilead is touting one such case in Trodelvy, which clamped down a full OK just under one year after it was initially cleared for use in triple-negative breast cancer. It’s also a broader approval — expanding the patient population to include those with unresectable locally advanced TNBC, not just metastatic cases. Patients must have received two or more prior systemic therapies, at least one of them for metastatic disease.
Immunomedics, the biotech that had labored on the antibody-drug conjugate over a lengthy 37-year stretch, had outlined the progression-free survival and overall survival data from the Phase III ASCENT study shortly after the initial approval last April.
A look at the numbers under the hood set off frenzied negotiations between Gilead’s Dan O’Day and Immunomedics’ Behzad Aghazadeh, culminating in a $21 billion buyout announced just ahead of ESMO, where detailed results were showcased.
According to the final data cut, Trodelvy reduced the risk of death in TNBC patients by 49%, with a median OS of 11.8 months, as opposed to the 6.9 months achieved by standard single-agent chemotherapy. PFS came in at a median of 4.8 months, compared to 1.7 months on chemotherapy (p<0.0001).
The full FDA endorsement now “positions sacituzumab govitecan-hziy as a potential standard of care for pre-treated TNBC,” said principal investigator Aditya Bardia, referring to the experimental name of the drug.
It also marks serious validation of Aghazadeh, the venBio investor who campaigned hard against selling the drug to Seattle Genetics, wrangled control of the company from its founders, kept the faith through a burning rejection and stepped in to make key decisions as executive chairman through some CEO turnover.
One of the first members in a growing class of drugs targeting the TROP2 receptor, Trodelvy is also being tested in urothelial cancer, non-small cell lung cancer, head and neck cancer, as well as endometrial cancer.