Biologics

Daiichi Sankyo and Merck Withdraw BLA for Lung Cancer

Daiichi Sankyo and Merck have withdrawn a BLA seeking accelerated approval for ifinatamab deruxtecan (I-DXd) for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The action was based on input from FDA indicating that “data supporting the application, including from the IDeate-Lung01 Phase 2 trial, do not satisfy requirements needed to support an accelerated approval for the proposed indication,” the companies say.

Daiichi Sankyo and Merck note that patient enrollment is continuing in the IDeate-Lung02 Phase 3 trial evaluating ifinatamab deruxtecan versus treatment of physician’s choice of chemotherapy (amrubicin, lurbinectedin or topotecan) in patients with relapsed ES-SCLC. “Enrollment into the IDeate-Lung02 Phase 3 trial is near completion and we look forward to assessing the potential for a future filing of ifinatamab deruxtecan with the FDA and other global regulatory authorities based on those results,” they say.

Additionally, there are two additional Phase 3 trials underway with ifinatamab deruxtecan in advanced/metastatic disease, including IDeate-Prostate01 for castration-resistant prostate cancer and IDeate-Esophageal01 for esophageal squamous cell carcinoma.

Ifinatamab deruxtecan is described as an investigational potential first-in-class B7-H3 directed ADC. “Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers,” according to the companies.

2 Charged in Counterfeit Ozempic Scheme

The U.S. Attorney’s Office for the Middle District of Florida and the Department of Justice’s Criminal Division have announced federal charges against Swapnadip Roy and Vicky Ramancha. The two Indian nationals have been charged with conspiracy and smuggling related to an alleged transnational counterfeit prescription drug distribution

Warning Letters Instructive on Documentation

Five FDA drug company 2026 Warning Letters should be studied by other manufacturers who want to learn more about the agency’s position on documentation defensibility, according to a Quality Digest online post. The post says that in each of the five letters, that were issued within seven weeks, a

Fresenius Kabi USA CGMP Violations

A 1/27-2/18 FDA inspection at the Fresenius Kabi USA drug manufacturing facility in Melrose Park, IL, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/22 Warning Letter says the three specific violations were: * failure to thoroughly investigate any unexplained discrepancy

Democratic Women in Congress Want Action on Estradiol Patch Shortage

Some 44 members of the congressional Democratic Women’s Caucus have written to FDA acting commissioner Kyle Diamantas and HHS secretary Robert F. Kennedy Jr., asking that they immediately address the ongoing shortage of estradiol transdermal patches that help manage menopause symptoms. A caucus statement (contains a link to the

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2 Charged in Counterfeit Ozempic Scheme

Warning Letters Instructive on Documentation

Fresenius Kabi USA CGMP Violations

Democratic Women in Congress Want Action on Estradiol Patch Shortage