Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

April 27, 2021

– Prescription Drug User Fee Act (PDUFA) Target Action Date Set for October 26, 2021

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788) for the treatment of adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (mNSCLC), as detected by an FDA-approved test, who have received prior platinum-based chemotherapy. Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations.

“Patients with EGFR Exon20 insertion+ mNSCLC face considerable challenges, as current treatment options provide limited benefit, resulting in poor survival outcomes,” said Christopher Arendt, head, Oncology Therapeutic Area Unit, Takeda. “We are excited to be one step closer to offering mobocertinib as an effective oral therapy for NSCLC patients with EGFR Exon20 insertions that have received prior platinum-based chemotherapy and look forward to continuing conversations with regulatory agencies in the U.S. and around the globe.”

The NDA for mobocertinib is primarily based on results from the Phase 1/2 trial, which is evaluating the safety and efficacy of oral mobocertinib in patients with mNSCLC. The application was submitted under the FDA’s accelerated approval program. The review is being conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), which provides a framework for concurrent submission and review of oncology products among international partners.

Takeda has established an Expanded Access Program (EAP) (NCT04535557) for patients in the U.S. who may be eligible to receive access to mobocertinib during the review of the NDA. Additional information about Takeda’s EAP is available here.

Learn more HERE

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For Immediate Release:

Today, the U.S. Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR (which contain abnormalities that affect the proper repair of DNA inside the cell), as determined by an FDA-approved test.

“Today’s approval of Jemperli is evidence of the FDA’s progress in applying precision medicine to expand treatment options for patients with cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “This immunotherapy was specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response in this unmet medical need population.”

Read the full release here.

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April 26, 2021


 NCODA Welcomes New Executive Council Member

Cazenovia, NY – NCODA, Inc. is pleased to announce our expanded leadership to the Executive Council. Lucius Daniel, PharmD, the Lead Clinical Pharmacy Specialist with Karmanos Specialty Pharmacy in Troy, Michigan, has joined the Executive Council as of April 2021.

Lucius has been a member of the Karmanos Cancer Center since March 2018, and has diverse pharmacy background with experience in medical affairs/market development in the pharmaceutical industry. Lucius earned his Bachelor of Science in Pharmacy from Wayne State University and completed his Doctor of Pharmacy studies at the University of Florida-Gainesville. He began his career in the pharmaceutical industry with Eli Lilly and Company, and later transitioned Merck and Company as the Regional Health Science Associate covering a large geography in Michigan. Lucius also has experience in retail pharmacy, and before joining the team at Karmanos Cancer Center held a position at McLaren Oakland as the 340(b) Program Manager.

“Over the last month NCODA has added another skilled and well-respected cancer care professional to our Executive Council,” said NCODA President Jim Schwartz, RPh. “Lucius is well positioned to help us continue executing on our Mission in 2021.” NCODA Founder and Executive Director Michael Reff, RPh, MBA noted, “Lucius has extensive experience working in an integrated delivery network. As NCODA grows, it is important that the organization has leaders with unique backgrounds and experiences so that we can continue to shape the cancer care landscape…and do it in a way that is Patient-Centered and Always Collaborative!”

For more information about NCODA’s Executive Council and general updates, visit ncoda.org.




NCODA, Inc. is a 501(c)(3) organization. Our Mission is to empower the medically-integrated oncology team to deliver positive, patient-centered outcomes by providing leadership, expertise, quality standards and best practices. For more information about NCODA’s Executive Council and general updates, visit www.ncoda.org.

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