- Immunomedics on Wednesday won U.S. approval for a new breast cancer drug, more than one year after the Food and Drug Administration rejected the New Jersey biotech's original application over manufacturing concerns.
- Trodelvy, as the drug will be marketed, is for women with an aggressive form of breast cancer that doesn't respond to standard hormonal therapies or targeted drugs like Herceptin. The FDA cleared Trodelvy for use in patients whose tumors have spread to other parts of the body, and who have already received two earlier treatments.
- The FDA's OK came roughly five weeks ahead of schedule, making Trodelvy another example of the speed at which the regulator is moving to approve new cancer drugs. Clearance for Trodelvy, which was based on data from a single-arm Phase 2 study, is conditional and will need to be confirmed by subsequent results.
Trodelvy is Immunomedics' first approved drug in its nearly four-decade-long corporate history. The biotech's transition from a research organization to a commercial-stage biotech, though, comes in the middle of a pandemic and at a time when drugmakers have largely grounded traditional in-person sales efforts.
Cancer drugs, though, appear to be less affected by disruption from the spread of the new coronavirus, chiefly due to the critical need for treatment.
Trodelvy, known up until now as sacituzumab govitecan, is for women with triple-negative breast cancer, a fast-moving tumor type with few treatment options. Drugs that target hormone receptors, like tamoxifen or fulvestrant, don't work well in this cancer type, nor do therapies targeting the HER2 protein, like Herceptin.
Treatment usually involves chemotherapy, but that can only stave off tumor growth for so long. Several estimates put median survival after initial diagnosis at 18 months or less. An immunotherapy from Roche was last year approved by the FDA for triple-negative breast cancer, but treatment was associated with only modest benefit.
"There is intense interest in finding new medications to help treat metastatic triple-negative breast cancer," said Richard Pazdur, head of the FDA's cancer division, in a statement. "Today’s approval provides patients who’ve already tried two prior therapies with a new option.”
Trodelvy isn't a wonder drug. Mid-stage data used by Immunomedics to support its application to the FDA showed only about a third of 108 patients treated with Trodelvy responded, and those responses typically lasted about 8 months.
Trodelvy was also associated with severe diarrhea and abnormally low counts of a type of white blood cell called neutrophils.
Increasingly, the FDA has been willing to clear new cancer drugs through to market based on early data, asking drugmakers to follow up with further study to support accelerated approvals.
Immunomedics' confirmatory trial, called ASCENT, was recently stopped early after a monitoring committee found evidence of the drug's benefit in the first 500 or so patients enrolled. Results are expected by mid-2020, but will likely come in the form of progression-free survival numbers — how long the drug keeps cancer from spreading — rather than overall survival.
Trodelvy is an antibody-drug conjugate, a type of treatment that pairs a toxic compound with a special protein designed to target tumor cells. In Trodelvy's case, that protein seeks out a receptor called Trop-2, which helps tumors grow, divide and spread.
Manufacturing problems at Immunomedics' plant in Morris Plains, New Jersey, led the FDA in January 2019 to reject the company's first attempt at winning approval for the drug. The agency later re-inspected the site and Immunomedics appears to have resolved the original issues.
But the CEO who led Immunomedics through its first go at approval, Michael Pehl, is no longer with the company, having resigned in February 2019. A long search for his replacement ended this month, with the appointment of former Ipsen and Novartis executive Harout Semerjian as CEO.