Immunonmedics (NASDAQ: IMMU) received regulatory approval from the FDA for Trodelvy (sacituzumab govitecan) for the treatment of metastatic Triple-Negative Breast Cancer (mTNBC) for patients that have had at least 2 prior therapies. The PDUFA date was June 2nd so this action is much earlier than expected. The company's journey to approval has not been easy. Over a year ago they received a Complete Response Letter (CRL) citing the Chemistry, Manufacturing and Control issues. Recently IMMU's confirmatory ASCENT study was stopped early by the Data Safety Monitoring Committee (DSMC) after it validated the safety of IMMU's Antibody Drug Conjugate (ADC) Trodelvy, The trial was for third line refractory mTNBC patients. This was welcome news for many cancer patients with no treatment options, but given the strong pipeline in TNBC they are in a race to commercialization as competitors like CytoDyn (OTCMKTS: CYDY) increase the heat.
US Launch Strategy - Virtual Launch?
Immunomedics is taking a go it alone strategy and is in the process of developing and prepping their own sales force in an atmosphere of social distancing. They still plan on using their original strategy that was based on reps who visited doctor's offices in a modified fashion. They are planning on a virtual launch. On the investor conference call the company was very optimistic about being able to quickly roll out their marketing plan using webinars and zoom meetings to take the place of traditional in-house visits in their quest to reach physicians. They want to be known as the leader in mTNBC and get key opinion leaders to embrace it as the standard of care (SOC). The early approval has created an issue for the company. The final data they need to make their medical claims will not be ready for another 3 months while
