Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

– FDA approval based on phase 3 COSMIC-311 pivotal trial, which demonstrated significant improvement in progression-free survival with CABOMETYX versus placebo –

– Exelixis is prepared to fully support expanded indication immediately –

– Application approved well ahead of Prescription Drug User Fee Act target action date of December 4, 2021 –

ALAMEDA, Calif.–(BUSINESS WIRE)–Sep. 17, 2021– Exelixis, Inc. (Nasdaq: EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy and who are radioactive iodine-refractory or ineligible. The FDA granted Breakthrough Therapy designation and Priority Review to CABOMETYX and its approval comes more than two months ahead of the Prescription Drug User Fee Act (PDUFA) target action date of December 4, 2021. DTC is the most common type of thyroid cancer in the U.S., and patients who are resistant to radioactive iodine treatment face a poor prognosis.1,2,3,4

“Before today, patients with radioactive iodine-refractory differentiated thyroid cancer who have progressed following prior VEGFR-targeted therapy were facing aggressive disease and no standard treatment option,” said Marcia S. Brose, M.D., Ph.D., Chief, Cancer Center Operation Sidney Kimmel Cancer Center at Jefferson Torresdale Hospital, Co-Director, Community Based Clinical Trials, Sidney Kimmel Cancer Center at Thomas Jefferson University, and principal investigator of COSMIC-311. “In the COSMIC-311 pivotal phase 3 trial, CABOMETYX extended the time patients live without progression of their cancer. The FDA approval of CABOMETYX is an important advancement for these patients who are badly in need of new treatment options.”

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Takeda’s EXKIVITY™ (mobocertinib) Approved by U.S. FDA as the First Oral Therapy Specifically Designed for Patients with EGFR Exon20 Insertion+ NSCLC

  • Approval based on Phase 1/2 trial results, which demonstrated clinically meaningful responses with a median duration of response (DoR) of approximately 1.5 years
  • Next-generation sequencing (NGS) companion diagnostic test approved simultaneously to support identification of patients with EGFR Exon20 insertion mutations

OSAKA, Japan, and CAMBRIDGE, Mass. September 15, 2021 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has approved EXKIVITY (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. EXKIVITY, which was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation from the FDA, is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations. This indication is approved under Accelerated Approval based on overall response rate (ORR) and DoR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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Bristol Myers Squibb has developed a 120-mg/12-mL vial.

This vial is available in addition to the current vial sizes (40 mg, 100 mg, and 240 mg).

For NDC codes and OPDIVO storage information, see the vial flashcard HERE.

Please ensure the 120-mg vial is included in your EHR for prescribing.

If you need help adding the 120-mg vial to your EHR, contact your BMS rep or call 1-855-OPDIVO-1 (1-855-673-4861) for live support and assistance, 8:00 AM to 8:00 PM ET, Monday – Friday.

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FOR IMMEDIATE RELEASE

SEPTEMBER 1, 2021

Media Contact:
Katie Edmiston | Marketing Manager
Katie.Edmiston@NCODA.org

 

NCODA Expands Patient and Caregiver Resource to Improve Understanding and Outcomes

CAZENOVIA, NY – September 1, 2021 – With the success of the highly utilized NCODA conceived OCE (Oral Chemotherapy Education) online resource, the collaboration with the Oncology Nursing Society (ONS), the Hematology/Oncology Pharmacy Association (HOPA), and the Association of Community Cancer Centers (ACCC), has now expanded to launch the Intravenous Cancer Treatment Education (IVE) website, ivecanceredsheets.com. This website, in joint effort between the oncology healthcare providers, is dedicated to forward thinking and to providing thorough education resources to improve patient understanding.

The IVE website provides healthcare workers the latest education material for Intravenous Cancer Treatments, communicating vital information to help caregivers and their patients. With a committee consisting of representatives from each of the organizations, a development process is structured to produce trusted and reliable education sheets that provide a robust amount of information on individual drugs and combination drug regimens. The sheets include common uses and treatment schedules, supportive medications drug interactions, side effect management and safe handling tips at home following treatment.

The website is an ongoing NCODA led and committee driven project where new regimens will be added ongoing. With the launch of the IVE website, users can access the first 15 sheets and begin providing them to their patients. As additional education sheets are added, the organizations will continue to communicate this information out to their member practices.

 

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About NCODA

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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FOR IMMEDIATE RELEASE

AUGUST 10, 2021

  

NCODA Structures Medically Integrated Pharmacy Accreditation

 

Cazenovia, New York – As the leading not-for-profit association for the patient-centered medically-integrated oncology community, NCODA, Inc. is excited to announce the new NCODA Center of Excellence (CoE) Medically Integrated Pharmacy (MIP) Accreditation Program. The program, based on compliance with the ASCO/NCODA Patient-Centered Standards for Medically Integrated Dispensing, focuses on enhanced patient care and quality of services. An Executive Accreditation Council and an Accreditation Working Group will provide guidance, insight and support for the new CoE MIP Accreditation Program.

“NCODA’s focus from day one has been patient-centered; to always deliver quality, value and financial viability resources to medically integrated oncology centers that will in turn enhance patient care,” said Jim Schwartz, RPh, NCODA Executive Council President. “Providing this Center of Excellence accreditation will only accelerate our Mission to bring the best care possible to every cancer patient and improve overall outcomes.”

Elizabeth Bell, NCODA’s Director of Medically Integrated Pharmacy Accreditation, will lead this initiative and work closely with both the Accreditation Executive Council and the Accreditation Working Group. Bell has over twenty years experience in healthcare accreditation, compliance and management. Elizabeth has managed quality and accreditation departments, developed healthcare quality initiatives and led statewide compliance audit teams. Most recently she served as the VP of Consulting Services for a healthcare accreditation consulting company.

“We are thrilled to have Elizabeth lead this program,” said Michael Reff, NCODA Executive Director. “Elizabeth’s background aligns perfectly to NCODA’s Mission and we look forward to how she will use her previous experience to enhance our resources to the benefit of our patients, our members and all stakeholders in the oncology community.”

NCODA holds itself accountable to serving the medically integrated dispensing community by delivering positive, patient-centered resources and programs to ensure the highest of quality and best practice standards are provided to the patient. NCODA set out on this accreditation process as a commitment to empower oncology centers to deliver the highest level of performance that brings sustainability and value. Over the past several months, program groundwork has been laid and gained great support from stakeholders including: community and health system oncology practices, pharmaceutical partners, professional and advocacy organizations, as well as PBMs and plans. Further details on NCODA’s Center of Excellence (CoE) Medically Integrated Pharmacy (MIP) Accreditation Program will be announced in the coming weeks.

 

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About NCODA

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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