Drug: sacituzumab govitecan
Used for: triple-negative breast cancer
Est. 2024 sales: $1.44 billion
Triple-negative breast cancer (TNBC) therapy sacituzumab govitecan didn't exactly sail through the FDA: A complete response letter (CRL) in early 2019 nearly sank its approval hopes. But drugmaker Immunomedics is taking a new tack with regulators––and it could help the drugmaker reach blockbuster sales.
Sacituzumab govitecan could reach $1.44 billion in 2024 global sales, according to EvaluatePharma, as a third-line treatment for late-stage, metastatic TNBC.
Immunomedics resubmitted its application for the drug in early December, and the FDA has a decision date set for June, the company said.
Sacituzumab govitecan is an antibody drug conjugate including the active ingredient in chemotherapy Onivyde. The chemotherapeutic treatment will be tasked with stacking up against Roche I-O therapy Tecentriq, which was approved to treat TNBC in March.
In a note to investors earlier this month, Cantor analyst Varun Kumar, Ph.D., posited that sacituzumab could be a strong candidate for an acquisition if it nabs an FDA approval as a third-line-or-later treatment. Kumar put the drug's possible acquisition value at $7.1 billion.
The CRL was only the start of Immunomedics' problems, though. When pressed by analysts after the CRL was made public, company executives dodged questions about whether the rejection stemmed from a preapproval inspection of its plant last year. The FDA was more forthcoming; it released a Form 483 from the inspection showing big issues with data integrity at the Morris Plains, New Jersey, plant where sacituzumab govitecan would be made.
A management shakeup ensued. CEO Michael Pehl hit the exit in February 2019, swiftly followed by R&D lead Robert Iannone, M.D., who later joined Jazz Pharmaceuticals. According to Immunomedics' website, both positions remain unfilled.
But Immunomedics said it has resolved its manufacturing problems and felt comfortable bringing sacituzumab govitecan back up for regulatory scrutiny.