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Clovis Oncology, Inc.

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FDA POSTS BRIEFING DOCUMENTS FOR ADVISORY COMMITTEE MEETING TO REVIEW CLOVIS ONCOLOGY’S ROCILETINIB FOR TREATMENT OF ADVANCED T790M-POSITIVE MUTANT EPIDERMAL GROWTH FACTOR RECEPTOR NON-SMALL CELL LUNG CANCER
BOULDER, Colo.--(BUSINESS WIRE)--Apr. 8, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) posted briefing materials in advance of the Oncologic Drugs Advisory Committee (ODAC) meeting to discuss accelerated approval of the New Drug Application (NDA) for rociletinib, an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the T790M mutation.

The ODAC meeting is scheduled to take place on April 12, 2016 from 8:30 a.m. ET to 1 p.m. ET. Briefing materials and webcast information can be found on the FDA website at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/O....

The FDA has set a target action date of June 28, 2016 for rociletinib under the Prescription Drug User Fee Act (PDUFA).

About T790M-Positive Mutant EGFR NSCLC
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Source: press release, 4/08/16. http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&I...

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Patrick J. Mahaffy, President and CEO, commented on the regulatory process for Rociletinib. He stated, "Now let me provide more of an update for each of our products in greater detail. First with rociletinib. Our regulatory filings submitted last July for Rociletinib for the treatment of patients with advanced EGFR mutant T790M positive non-small cell lung cancer remain under review in both U.S. and the EU. In the U.S., we’re actively preparing for the now confirmed ODAC panel discussion to take place on April 12. Our team is working very hard in preparation for the meeting and we remain committed to making this drug commercially available for patients with EGFR driven T790M positive non-small cell lung cancer for whom additional treatment options are very much needed. As I noted earlier, our PDUFA date is June 28, 2016."
Source: Q4 2015 earnings conference call, 2/25/16.

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CLOVIS ONCOLOGY ANNOUNCES ROCILETINIB NEW DRUG APPLICATION SCHEDULED FOR PRESENTATION AT UPCOMING FDA ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING
BOULDER, Colo.--(BUSINESS WIRE)--Feb. 12, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on April 12, 2016. Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.

The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.

“We are actively preparing for this advisory committee meeting and look forward to the discussion about rociletinib,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “New treatments are needed for this hard-to-treat patient population, and we believe that rociletinib represents an important new option for patients with mutant EGFR T790M-positive lung cancer.”
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Source: press release, 2/12/16. http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&I...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Rociletinib (CO-1686) EGFR mutationOncologyNon-Small Cell Lung Cancer (NSCLC) (1st line)Epidermal growth factor receptor (EGFR) inhibitorEpidermal growth factor

Mechanism of action: Rociletinib (CO-1686) is an orally available small molecule, irreversible inhibitor of epidermal growth factor receptor (EGFR) with potential antineoplastic activity. EGFR inhibitor CO-1686 binds to and inhibits mutant forms of EGFR, including T790M, thereby leading to cell death of resistant tumor cells. Compared to other EGFR inhibitors, CO-1686 inhibits T790M, a secondary acquired resistance mutation, as well as other mutant EGFRs and may have therapeutic benefits in tumors with T790M-mediated resistance to other EGFR tyrosine kinase inhibitors. This agent shows minimal activity against wild-type EGFR, hence does not cause certain dose-limiting toxicities.

Phase of Development: Filed

Event Type: Regulatory FDA: Advisory Committee Meeting

Dates: 2016-04-12

Results:

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CLOVIS ONCOLOGY PROVIDES UPDATE ON FDA ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING TO REVIEW ROCILETINIB FOR TREATMENT OF ADVANCED T790M-POSITIVE MUTANT EPIDERMAL GROWTH FACTOR RECEPTOR NON-SMALL CELL LUNG CANCER
BOULDER, Colo.--(BUSINESS WIRE)--Apr. 12, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) met to discuss approval of the New Drug Application (NDA) for rociletinib, an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the T790M mutation.

The Committee recommended that the FDA wait to see results from TIGER-3, Clovis’ ongoing Phase 3, randomized, controlled trial of rociletinib, before making a decision on approval of the treatment. Patient enrollment for the trial is expected to complete in late 2018.

“We are disappointed with today’s outcome, as we believe in the strength of the data we presented for rociletinib,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We will work with the FDA to evaluate the best path forward as it continues to review our application.”

The FDA set a target action date of June 28, 2016 under the Prescription Drug User Fee Act (PDUFA). The TIGER-3 trial, Clovis’ confirmatory randomized, controlled Phase 3 study for rociletinib, is ongoing, with patient enrollment expected to complete in late 2018.
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Source: press release, 4/12/16. http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&I...

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