As the year wraps up, there are still some PDUFA dates on the agency’s calendar. Read on for this week’s.
Although much of the U.S. Food and Drug Administration (FDA)’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. Read on for this week’s.
MacroGenics’ Margetuximab for Metastatic HER2+ Breast Cancer
MacroGenics, based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. In May 2020, the FDA notified MacroGenics that it was no longer planning to hold an Oncologic Drugs Advisory Committee (ODAC) meeting, but expected to hit the PDUFA date of December 17.
“Since submitting the BLA for margetuximab, we have worked collaboratively with the FDA to answer the Agency’s questions as they arise,” said Scott Koenig, president and chief executive officer of MacroGenics, in May. “We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer.”
Margetuximab is an investigational, Fc-engineered, monoclonal antibody targeting HER2. About 15 to 20% of breast cancers cases are HER2+, and antibody-based therapies targeting HER2 have significantly improved outcomes of patients with HER2+ breast cancer. But metastatic breast cancer is still an unmet need.
The drug is also being evaluated in combination with checkpoint inhibitors, and in patients with HER2+ gastroesophageal cancer.
MacroGenics partnered with Zai Labs, based in Shanghai, China and San Francisco, on the drug. The deal was announced in November 2018, when the two companies inked an exclusive collaboration and license deal involving three immuno-oncology programs from MacroGenics’ pipeline: margetuximab; MGD013, a first-in-class bispecific DART molecule designed to provide coordinate blockade of PD-1 and LAG-3 for possible treatment of solid tumors and hematological malignancies; and an undisclosed multi-specific TRIDENT molecule that is in preclinical development.
Zai Labs obtained regional development and commercialization rights for the programs in mainland China, Hong Kong, Macau and Taiwan. Zai Lab is leading clinical development in its territory.
“We believe Zai Lab is an ideal partner to enable us to expand MacroGenics’ global efforts to address patient populations with high unmet medical needs such as gastric cancer,” Koenig said at the time. “Zai has a strong track record of rapidly progressing the development of innovative product candidates in China and is well on its way to building its commercial platform. Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region.”
Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan
Amgen has a target action date of December 19 for its BLA for ABP 798, a biosimilar to Genentech’s Rituxan (rituximab). A biosimilar is like a generic version of a biologic, but unlike a generic, which is a direct copycat of a branded drug, a biosimilar is “similar,” and as a result has to undergo a regulatory and clinical trial process similar to that of new drugs.
Rituxan is approved for non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV). The drug is an anti-CD20 antibody.
The biosimilar is a collaboration between Amgen and Allergan, which was formed when Allergan was Watson Pharmaceuticals in December 2011. That collaboration was to develop and commercialize four oncology antibody biosimilar therapies.
The companies filed in December 2019, and included analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data from two clinical trials. The studies found no clinically meaningful differences between ABP 798 and Rituxan.
“The U.S. filing for ABP 798 marks an important milestone for Amgen, as it affirms our commitment to providing high quality biosimilars that offer more life-altering biological treatment options and contribute to the sustainability of healthcare systems,” said David M. Reese, Amgen’s executive vice president of Research and Development, in December. “We look forward to working with the FDA to bring ABP 798 to market.”
