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Exelixis, Inc.

Partner : Ipsen

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Michael Morrissey, PhD, President and CEO, gave guidance for the regulatory decision regarding the MAA for Cabozantinib. He stated, "As I mentioned earlier, we filed our MMA for advanced RCC in the EU in early 2016 and could have approval before the end of the year. It's in that context, that I am pleased to announce today the deal with Ipsen as our partner to commercialize Cabozantinib in markets outside of the U.S., Canada and Japan. We believe the deal economics reflect both the strength of the METEOR data set as well as Ipsen's commitment to Cabozantinib in RCC and importantly to the development of a broader Cabozantinib franchise."
Source: Q4 2015 earnings conference call, 2/29/16.

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Exelixis Announces European Medicines Agency Acceptance of Marketing Authorization Application for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Jan. 28, 2016-- Exelixis, Inc. (NASDAQ:EXEL) today announced the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. The completion of the MAA validation process confirms that the submission is sufficient to permit a substantive review for marketing authorization in the European Union.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) previously granted accelerated assessment to cabozantinib for advanced RCC. As a result, the MAA will be eligible for a 150-day review, versus the standard 210 days (excluding clock stops when information is requested by CHMP).

The MAA is based on the results of METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with advanced RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. In July 2015, Exelixis announced top-line results from METEOR demonstrating that the trial had met its primary endpoint of improving progression-free survival; compared with everolimus, a standard of care for second line RCC therapy, cabozantinib was associated with a 42% reduction in the rate of disease progression or death. These data were later presented at the European Cancer Congress in September 2015 and concurrently published in The New England Journal of Medicine.

In the United States, in late December 2015, Exelixis announced that it completed the submission of its rolling New Drug Application (NDA) for cabozantinib as a treatment for patients with advanced RCC who have received one prior therapy. The U.S. Food and Drug Administration (FDA) subsequently determined the NDA to be sufficiently complete to permit a substantive review, granted Priority Review, and assigned a Prescription Drug User Fee Act action date of June 22, 2016. The NDA will be considered officially filed 60 days from the date of the completion of the submission, or February 20, 2016. The FDA previously granted Breakthrough Therapy and Fast Track designations to cabozantinib for its potential advanced RCC indication.

Cabozantinib is currently marketed in capsule form under the brand name COMETRIQ® in the United States for the treatment of progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. COMETRIQ is not indicated for patients with RCC. In the METEOR trial, and all other cancer trials currently underway, Exelixis is investigating a tablet formulation of cabozantinib distinct from the COMETRIQ capsule form. The tablet formulation of cabozantinib is the subject of the MAA for advanced RCC.
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Source: press release, 1/28/16. http://www.exelixis.com/investors-media/press-releases

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Exelixis Submits Marketing Authorization Application in the European Union for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Jan. 11, 2016-- Exelixis, Inc. (NASDAQ:EXEL) today announced that it has submitted a Marketing Authorization Application (MAA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy to the European Medicines Agency (EMA). The EMA will now conduct its standard validation process to determine whether the submission is sufficient to permit a substantive review for marketing authorization in the European Union.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) previously granted accelerated assessment to cabozantinib for advanced RCC. As a result, if validated, the MAA may be eligible for a 150-day review, versus the standard 210 days (excluding clock stops when information is requested by CHMP).

"The regulatory submission in the European Union follows our recent U.S. filing, and is an integral component of our plan to bring an important new treatment option for advanced kidney cancer to patients in need," said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. "As we seek to maximize the opportunity for the cabozantinib franchise on a worldwide basis, our discussions with potential partners for territories outside of the United States continue to advance. At the same time, we are making significant progress on our commercial readiness to market cabozantinib for advanced RCC in the United States, if approved."

The MAA is based on results of METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with advanced RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. In July 2015, Exelixis announced top-line results from METEOR demonstrating that the trial had met its primary endpoint of improving progression-free survival; compared with everolimus, cabozantinib was associated with a 42% reduction in the rate of disease progression or death. These data were later presented at the European Cancer Congress in September 2015 and concurrently published in The New England Journal of Medicine.

In the United States, on December 23, 2015, Exelixis announced that it completed the submission of its rolling New Drug Application for cabozantinib as a treatment for patients with advanced RCC who have received one prior therapy; the U.S. Food and Drug Administration is currently conducting its preliminary review of the application’s suitability for full review and has not yet assigned a potential Prescription Drug User Fee Act date. The FDA previously granted Breakthrough Therapy and Fast Track designations to cabozantinib for its potential advanced RCC indication; in its NDA, Exelixis has requested Priority Review designation.

Cabozantinib is currently marketed in capsule form under the brand name COMETRIQ® in the United States for the treatment of progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. COMETRIQ is not indicated for patients with RCC. In the METEOR trial, and all other cancer trials currently underway, Exelixis is investigating a tablet formulation of cabozantinib distinct from the COMETRIQ capsule form. The tablet formulation of cabozantinib is the subject of the MAA for advanced RCC.
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Source: press release, 1/11/16. http://www.exelixis.com/investors-media/press-releases

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Cabozantinib - Renal cell carcinomaUrologyRenal cell carcinomaTyrosine kinase inhibitorc-Met and VEGFR-2

Mechanism of action: Cabozantinib is an orally bioavailable, small molecule receptor tyrosine kinase (RTK) inhibitor with potential antineoplastic activity. Cabozantinib strongly binds to and inhibits several tyrosine receptor kinases. Specifically, cabozantinib appears to have a strong affinity for the hepatocyte growth factor receptor (Met) and vascular endothelial growth factor receptor 2 (VEGFR2), which may result in inhibition of tumor growth and angiogenesis, and tumor regression. This agent has also been shown to inhibit mast/stem cell growth factor (KIT), FMS-like tyrosine kinase 3 (Flt3) and tyrosine-protein kinase receptor (Tie-2).

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2016-09-16

Results:

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European Commission Approves CABOMETYX™ (cabozantinib) Tablets for the Treatment of Advanced Renal Cell Carcinoma Following VEGF-Targeted Therapy
– CABOMETYX is the first and only therapy approved in the European Union to demonstrate improved overall survival, progression-free survival and objective response rate in a large, randomized phase 3 trial of patients with advanced kidney cancer –

– Approval of CABOMETYX in European Union triggers $60 million milestone payment to Exelixis under licensing agreement with Ipsen –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sep. 14, 2016-- Exelixis, Inc. (NASDAQ:EXEL) today announced that the European Commission (EC) has approved CABOMETYX™ (cabozantinib) tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. CABOMETYX was granted accelerated assessment by the European Medicines Agency, and is the first therapy to demonstrate in a phase 3 trial for patients with advanced RCC, robust and clinically meaningful improvements in all three key efficacy parameters — overall survival (OS), progression-free survival (PFS) and objective response rate (ORR). This approval allows for the marketing of CABOMETYX in all 28 member states of the European Union, Norway and Iceland.

EC approval of CABOMETYX triggers a $60 million milestone payment to Exelixis under the licensing agreement with Ipsen for the commercialization and further development of CABOMETYX indications outside of the United States, Canada and Japan. The approval is based on the results of the large, randomized phase 3 METEOR trial.

“The marketing authorization of CABOMETYX by the European Commission to treat patients with advanced renal cell carcinoma reflects the strong efficacy results observed with cabozantinib in the phase 3 METEOR trial, and is an important milestone in our collaboration with Ipsen,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “This marketing authorization helps address an unmet medical need in Europe by providing patients with a new therapy that slows disease progression and prolongs overall survival. We look forward to further examining the use of CABOMETYX in earlier lines of therapy and in other difficult-to-treat cancers.”
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Source: press release, 9/14/16. http://www.exelixis.com/investors-media/press-releases

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