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FDA Approval in RCC, ODAC Meetings Scheduled in TGCT and AML, and More

Gina Columbus
Published: Tuesday, Apr 30, 2019



Today-

An FDA approval in renal cell carcinoma, Oncologic Drug Advisory Committee meetings scheduled in tenosynovial giant cell tumor and acute myeloid leukemia, the launch of a new HER2 assay, and the announcement of the 2019 Giants of Cancer Care inductees.

Welcome to OncLive News Network! I'm Gina Columbus.

The FDA has approved pembrolizumab in combination with axitinib for the frontline treatment of patients with advanced renal cell carcinoma.

The approval is based on findings from the phase III KEYNOTE-426 trial, which demonstrated that the frontline combination significantly improved overall response rates, progression-free, and overall survival compared with sunitinib in patients with advanced RCC. Moreover, data showed that the combination led to a 47% reduction in the risk of death versus sunitinib.

At a median follow-up of 12.8 months, results showed that the median OS was not reached in either arm. The median progression-free survival was 15.1 months for pembrolizumab/axitinib and 11.1 months with sunitinib. With the combination, there was a 31% reduction in the risk of disease progression.

This is the first anti-PD-1 therapy that is approved as part of a combination regimen that significantly improved OS, PFS, and ORR compared with sunitinib in this patient population.

***********************************

The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for May 14, 2019, to discuss a new drug application for pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor.

The agency granted a priority review designation to the application for pexidartinib in February 2019. The decision was based on findings from the phase III ENLIVEN study, which showed a superior overall response rate with pexidartinib at 39.3% compared with 0% with placebo, after 24 weeks of treatment based on central review of MRI scans.

Additionally, the FDA scheduled a meeting for the same date to discuss the NDA for quizartinib tablets for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia. Both therapies are developed by Daiichi Sankyo, Inc.

The FDA granted a priority review to the NDA for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive AML in November 2018, with an original action date of May 25, 2019. In April 2019, the agency added 3 months to the review period for the application, allowing the agency to review additional data.

The NDA is based on results from the phase III QuANTUM-R study, which showed that quizartinib led to a 24% reduction in the risk of death versus salvage chemotherapy in patients with FLT3-ITD–positive relapsed/refractory AML following frontline treatment with or without hematopoietic stem cell transplantation.

The FDA will consider the recommendations of the ODAC panel following each hearing. Under the Prescription Drug User Fee Date, the FDA must make a decision on the approval for pexidartinib by August 3, 2019, and the deadline for the approval of quizartinib is May 25, 2019.

***********************************

A new VENTANA HER2 dual in situ hybridization companion diagnostic assay has launched to identify HER2 amplification for patients with breast cancer and gastric cancer who could receive trastuzumab.

The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is currently available in Europe, the Middle East, Africa, Latin America, and Asia Pacific. An application for the test will be submitted to the FDA for approval.

The brightfield assay is designed to identify patients who have HER2-positive breast or gastric cancer and would be candidates to receive trastuzumab.

Additionally, the test is devised to be completed within the same day, which Roche, the manufacturer of the assay, stated is quicker than most HER2 confirmatory tests. Additionally, the assay is fully automated on BenchMark immunohistochemistry/ISH instruments.

Results from the new assay can be read via microscopy, which eliminates the need for a specialized fluorescence microscope.

*********************************

The inductees of the 2019 Giants of Cancer Care recognition program have been announced. This year, OncLive will honor 15 healthcare professionals who are advancing the field of oncology via their contributions in research and clinical practice. The winners will be celebrated at the seventh annual Giants of Cancer Care Winners’ Reception on May 30 at the Adler Planetarium in Chicago.

This year’s Giants of Cancer Care® inductees are the following:
  • Breast Cancer: Dr. Eric P. Winer of Dana-Farber Cancer Institute/Harvard Medical School
  • Cancer Diagnostics – Dr Charles M. Perou, of the University of North Carolina School of Medicine/Lineberger Comprehensive Cancer Center
  • Community Outreach, Education, and/or Cancer Policy: Dr. Richard Pazdur, of the FDA
  • Gastrointestinal Cancer: Dr. Alan P. Venook of the University of California, San Francisco/Helen Diller Family Comprehensive Cancer Center
  • Genitourinary Cancer: Dr. Bernard J. Escudier, of the Institute Gustave Roussy
  • Gynecologic Malignancies: Dr. Beth Y. Karlan, of Cedars-Sinai Medical Center
  • Leukemia: Dr. Frederick R. Appelbaum, of Fred Hutchinson Cancer Research Center/University of Washington
  • Lung Cancer – Dr. David H. Johnson, of The University of Texas Southwest Medical Center
  • Lymphoma: Dr. Saul A. Rosenberg, of Stanford University
  • Melanoma & Other Skin Cancers: Dr. F. Stephen Hodi of Dana-Farber Cancer Institute
  • Myeloma: Dr. S. Vincent Rajkumar of Mayo Clinic
  • Pediatric Oncology: Dr. Donald Pinkel of St. Jude Children's Research Hospital
  • Prevention/Genetics: Henry T. Lynch M.D., Ph.D., of Creighton University
  • Supportive, Palliative, and/or Geriatric Care: Dr. Jamie H. Von Roenn of the American Society of Clinical Oncology
  • Translational Science: Dr Susan B. Horwitz, of Albert Einstein College of Medicine

Congratulations to the 2019 Giants of Cancer Care!

*********************************

This week, we sat down with Dr Geoffrey Thomas Gibney, of MedStar Georgetown University Hospital, to discuss gene mutations in melanoma.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
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Today-

An FDA approval in renal cell carcinoma, Oncologic Drug Advisory Committee meetings scheduled in tenosynovial giant cell tumor and acute myeloid leukemia, the launch of a new HER2 assay, and the announcement of the 2019 Giants of Cancer Care inductees.

Welcome to OncLive News Network! I'm Gina Columbus.

The FDA has approved pembrolizumab in combination with axitinib for the frontline treatment of patients with advanced renal cell carcinoma.

The approval is based on findings from the phase III KEYNOTE-426 trial, which demonstrated that the frontline combination significantly improved overall response rates, progression-free, and overall survival compared with sunitinib in patients with advanced RCC. Moreover, data showed that the combination led to a 47% reduction in the risk of death versus sunitinib.

At a median follow-up of 12.8 months, results showed that the median OS was not reached in either arm. The median progression-free survival was 15.1 months for pembrolizumab/axitinib and 11.1 months with sunitinib. With the combination, there was a 31% reduction in the risk of disease progression.

This is the first anti-PD-1 therapy that is approved as part of a combination regimen that significantly improved OS, PFS, and ORR compared with sunitinib in this patient population.

***********************************

The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for May 14, 2019, to discuss a new drug application for pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor.

The agency granted a priority review designation to the application for pexidartinib in February 2019. The decision was based on findings from the phase III ENLIVEN study, which showed a superior overall response rate with pexidartinib at 39.3% compared with 0% with placebo, after 24 weeks of treatment based on central review of MRI scans.

Additionally, the FDA scheduled a meeting for the same date to discuss the NDA for quizartinib tablets for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia. Both therapies are developed by Daiichi Sankyo, Inc.

The FDA granted a priority review to the NDA for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive AML in November 2018, with an original action date of May 25, 2019. In April 2019, the agency added 3 months to the review period for the application, allowing the agency to review additional data.

The NDA is based on results from the phase III QuANTUM-R study, which showed that quizartinib led to a 24% reduction in the risk of death versus salvage chemotherapy in patients with FLT3-ITD–positive relapsed/refractory AML following frontline treatment with or without hematopoietic stem cell transplantation.

The FDA will consider the recommendations of the ODAC panel following each hearing. Under the Prescription Drug User Fee Date, the FDA must make a decision on the approval for pexidartinib by August 3, 2019, and the deadline for the approval of quizartinib is May 25, 2019.

***********************************

A new VENTANA HER2 dual in situ hybridization companion diagnostic assay has launched to identify HER2 amplification for patients with breast cancer and gastric cancer who could receive trastuzumab.

The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is currently available in Europe, the Middle East, Africa, Latin America, and Asia Pacific. An application for the test will be submitted to the FDA for approval.

The brightfield assay is designed to identify patients who have HER2-positive breast or gastric cancer and would be candidates to receive trastuzumab.

Additionally, the test is devised to be completed within the same day, which Roche, the manufacturer of the assay, stated is quicker than most HER2 confirmatory tests. Additionally, the assay is fully automated on BenchMark immunohistochemistry/ISH instruments.

Results from the new assay can be read via microscopy, which eliminates the need for a specialized fluorescence microscope.

*********************************

The inductees of the 2019 Giants of Cancer Care recognition program have been announced. This year, OncLive will honor 15 healthcare professionals who are advancing the field of oncology via their contributions in research and clinical practice. The winners will be celebrated at the seventh annual Giants of Cancer Care Winners’ Reception on May 30 at the Adler Planetarium in Chicago.

This year’s Giants of Cancer Care® inductees are the following:
  • Breast Cancer: Dr. Eric P. Winer of Dana-Farber Cancer Institute/Harvard Medical School
  • Cancer Diagnostics – Dr Charles M. Perou, of the University of North Carolina School of Medicine/Lineberger Comprehensive Cancer Center
  • Community Outreach, Education, and/or Cancer Policy: Dr. Richard Pazdur, of the FDA
  • Gastrointestinal Cancer: Dr. Alan P. Venook of the University of California, San Francisco/Helen Diller Family Comprehensive Cancer Center
  • Genitourinary Cancer: Dr. Bernard J. Escudier, of the Institute Gustave Roussy
  • Gynecologic Malignancies: Dr. Beth Y. Karlan, of Cedars-Sinai Medical Center
  • Leukemia: Dr. Frederick R. Appelbaum, of Fred Hutchinson Cancer Research Center/University of Washington
  • Lung Cancer – Dr. David H. Johnson, of The University of Texas Southwest Medical Center
  • Lymphoma: Dr. Saul A. Rosenberg, of Stanford University
  • Melanoma & Other Skin Cancers: Dr. F. Stephen Hodi of Dana-Farber Cancer Institute
  • Myeloma: Dr. S. Vincent Rajkumar of Mayo Clinic
  • Pediatric Oncology: Dr. Donald Pinkel of St. Jude Children's Research Hospital
  • Prevention/Genetics: Henry T. Lynch M.D., Ph.D., of Creighton University
  • Supportive, Palliative, and/or Geriatric Care: Dr. Jamie H. Von Roenn of the American Society of Clinical Oncology
  • Translational Science: Dr Susan B. Horwitz, of Albert Einstein College of Medicine

Congratulations to the 2019 Giants of Cancer Care!

*********************************

This week, we sat down with Dr Geoffrey Thomas Gibney, of MedStar Georgetown University Hospital, to discuss gene mutations in melanoma.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
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