A roundup of manufacturing news from Astellas and Novartis. Highlights below. 

* Astellas Receives Complete Response Letter from FDA Over Mfg Issue 
* Novartis Expands Radiopharma Mfg in the US 

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Astellas Receives Complete Response Letter from FDA Over Mfg Issue 
The US Food and Drug Administration (FDA) has issued a Complete Response Letter to Astellas Pharma due to manufacturing issues in its biologics license application (BLA) for zolbetuximab, an investigational agent for treating stomach cancer or cancer of the esophagus. Specifically, the drug is being evaluated for treating locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma (a rare type of cancer of the esophagus) whose tumors are claudin (CLDN) 18.2 positive.  

The company says that FDA said that the agency cannot approve the BLA by the Prescription Drug User Fee Act (PDUFA) action date of January 12, 2024, due to unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab. The company said that the FDA has not raised any concerns related to the clinical data, including efficacy or safety, of zolbetuximab, and is not requesting additional clinical studies. Astellas says it is working with the FDA and the third-party manufacturer to establish a timeline to resolve the agency’s feedback. The company says that no other Astellas products are affected. 

Regulatory applications for zolbetuximab are also under review in several other countries and regions, including Japan, Europe, and China. 

Source: Astellas 

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Novartis Expands Radiopharma Mfg in the US 
The US Food and Drug Administration (FDA) has granted Novartis approval for commercial manufacturing of its radiopharmaceutical, Pluvicto (lutetium (177Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan), at the company’s new 70,000-square-foot large-scale radioligand therapy (RLT) manufacturing facility in Indianapolis, Indiana.  

The Indianapolis facility is built to manufacture RLTs and includes space for continued line expansion including plans for fully automated lines.  

Novartis has four active RTL manufacturing facilities and a RLT production capacity of 250,000 doses in 2024 and beyond. The new site in Indianapolis will supply patients in the US and eventually in Canada, upon approval, together with the company’s Millburn, New Jersey, site The site in Ivrea, Italy will continue to supply patients in and outside the US while the company’s facility in Zaragoza, Spain, will solely provide RLTs for patients outside the US. 

Novartis recently announced that supply of Pluvicto is unconstrained. Having doubled weekly production, Novartis says it currently has more than sufficient supply to treat patients within two weeks of diagnosis and is committed to improving access to its RLTs by adding more treatment sites in closer proximity to patients over the coming months (as reported on January 5, 2024). . 

Source: Novartis