Nearly a year after surprise rejection, Immunomedics returns to FDA
As last Christmas approached, analysts anticipated a potential blockbuster from Immunomedics. Instead, they got pharma coal: a CRL.
Now, nearly a year after the FDA first spurned Immunomedics’ lead drug, the ADC biotech is returning to plead their case again. They have resubmitted their BLA, seeking accelerated approval for sacituzumab govitecan for triple-negative metastatic breast cancer.
Immunomedics said the FDA noted manufacturing issues in their rejection. Soon after, it emerged that the agency had previously cited them for a breach of data integrity in the months leading up to their PDUFA, although the publicly released report is heavily redacted and it remains unclear if the data breach was directly connected to the FDA rejection.
The rejection triggered upper-level changes at a company that had gone decades without a drug approval and bet big on this drug reaching market. CEO Michael Pehl left days after the data breach report became public in February. Pehl had joined in 2017 as part of a shakeup that saw activist investors oust the husband-and-wife leadership team and nix a Seattle Genetics $300-million upfront, $1.7 billion down-the-road deal they saw as undervaluing the asset.
Pehl has not been officially replaced, although the company named Scott Canute to lead a CRL response team and Behzad Aghazadeh, the venBio vet who led the activist takeover has stepped in to oversee strategy and business operations.
Immunomedics told Endpoints News in an email that it met with the FDA in May and “validated” a CRL response plan and gave a “successful update” in September.
“The FDA was very favorable towards our plan,” they said.
Unlike the EMA, the FDA does not reveal the reasons for rejections. But the data breach report, written after an August inspection, was all but damning. “There is no assurance that samples and batch records form the [redacted] process validation and commercial batches manufactured prior to February 2018 were not impacted by the data integrity breach,” agency inspectors wrote. In a 13-point document, they listed poor retesting procedures, backdating documents, manipulation of bioburden samples, and facility design flaws, among other issues.
Immunomedics said they addressed the agency’s manufacturing concerns prior to the FDA’s first decision. Expecting an approval, they hired a sales force to market the drug and told Endpoints they had been in other manufacturing and post-marketing discussions.
“These matters were resolved during the review period last year,” the company wrote to Endpoints today of the data concerns, “and we have further invested significant resources this year to accelerate our quality improvement plan, and plan for a successful potential PAI as part of the resubmission.”
Sacituzumab govitecan, or IMMU-132, is an antibody drug conjugate that is designed to deliver a specific payload directly to the tumor. In a Phase II clinical trial published in the New Engalnd Journal of Medicine, the drug had a 33.3% response rate and showed a median progression-free survival of 5.5 months.