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Feb. 26, 2015

Amgen Announces The European Medicines Agency Acceptance Of Kyprolis® (Carfilzomib) Marketing Authorization Application For The Treatment Of Relapsed Multiple Myeloma

THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Feb. 26, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and its subsidiary Onyx Pharmaceuticals, Inc., today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) of Kyprolis® (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The MAA has been granted accelerated assessment by the EMA.

Kyprolis is a proteasome inhibitor, one of the classes of drugs used to treat multiple myeloma, an incurable blood cancer affecting approximately 89,000 people in Europe.1 Nearly all patients with the disease experience periods of remission, followed by relapses and eventually their disease becomes resistant to treatment.

"Achieving deep and durable responses for patients with relapsed multiple myeloma is critical towards extending the time they live without their disease progressing," said Pablo J. Cagnoni, M.D., president, Onyx Pharmaceuticals, Inc. "We look forward to working with European regulators to potentially make this important medication available."

The MAA includes data from the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial as well as other relevant data.

Kyprolis previously received orphan drug designation by the EMA in the European Union (EU). Orphan designation is granted for medicines intended for the treatment, prevention or diagnosis of a disease that is life threatening and has a prevalence in the EU of no more than five in 10,000. The intended medicine must aim to provide significant benefit to those affected by the condition.2

Kyprolis was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in July 2012. Kyprolis is also approved for use in Argentina, Israel and Mexico.3-5
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Source: press release, 2/27/15. http://wwwext.amgen.com//media/media_pr_detail.jsp?year=2015&releaseID=2...

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Sep. 2, 2014

Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agency

First Marketing Authorization Application for an Oncolytic Immunotherapy in the European Union

THOUSAND OAKS, Calif., Sept. 2, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) via the centralized procedure for talimogene laherparepvec seeking approval for the treatment of adults with melanoma that is regionally or distantly metastatic. Talimogene laherparepvec is an investigational oncolytic immunotherapy administered as an intralesional injection that is designed to initiate a systemic anti-tumor immune response. If approved, talimogene laherparepvec will represent the first in a class of novel agents known as oncolytic immunotherapies.

The MAA for talimogene laherparepvec contains data from more than 400 patients and is based on a global, randomized, open-label Phase 3 trial evaluating the safety and efficacy of talimogene laherparepvec in patients with stage IIIB, IIIC or IV melanoma when resection was not recommended compared to granulocyte-macrophage colony-stimulating factor (GM-CSF).

"The submission of the Marketing Authorization Application in Europe for talimogene laherparepvec brings us a step closer to helping address an unmet medical need for patients with metastatic melanoma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "This regulatory milestone, on the heels of our Biologics License Application submission to the U.S. FDA, represents an important step for our pipeline and we look forward to working with the European Medicines Agency as it conducts its review of talimogene laherparepvec."

Melanoma is a type of skin cancer that is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for providing the pigment to skin.1 Melanoma is the most aggressive and serious form of skin cancer. Currently, 132,000 melanoma cases occur globally each year.2 The number of people with melanoma is expected to rise considerably worldwide, with more than 279,000 projected new cases by the year 2020.3 Outcomes are substantially worse for people with regional and distantly metastatic disease, with high risk of recurrence for Stage IIIB, IIIC, and IV melanoma.4

Melanoma is considered to be advanced when it has spread, or metastasized, from the origin site to deeper parts of the skin or other organs such as the lymph nodes, lungs or other parts of the body distant from the primary tumor site.5
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Source: press release, 9/02/14. http://wwwext.amgen.com//media/media_pr_detail.jsp?year=2014&releaseID=1...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Imlygic (OncoVEX GM-CSF) (talminogene laherparepvec) (2) MelanomaOncologyMelanoma (metastatic)Viral and immunostimulated antineoplasticCancer cells

Mechanism of action: Imlygic (OncoVEX GM-CSF) (talminogene laherparepvec) is an oncolytic, recombinant herpes simplex type-1 virus (HSV) encoding human cytokine granulocyte-macrophage colony stimulating factor (GM-CSF) with potential immunostimulating and antineoplastic activities. Upon administration, talminogene laherparepvec selectively infects and replicates in tumor cells, thereby inducing tumor cell lysis. In addition, expressed GM-CSF may stimulate a cytotoxic T cell response against tumor cells, resulting in immune-mediated tumor cell death in addition to HSV-mediated oncolytic tumor cell death.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2015-12-25

Results:

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European Commission Approves Amgen's IMLYGIC™ (talimogene laherparepvec) As First Oncolytic Immunotherapy In Europe

Pivotal Trial Showed IMLYGIC Significantly Increased Durable Response Rates in Patients With Unresectable Melanoma That is Regionally or Distantly Metastatic
IMLYGIC is Approved in the European Union Specifically for Early Stage Metastatic Patients

THOUSAND OAKS, Calif., Dec. 18, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the European Commission has approved the use of IMLYGIC™ (talimogene laherparepvec) for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a), with no bone, brain, lung or other visceral disease. IMLYGIC is the first oncolytic immunotherapy to demonstrate therapeutic benefit for patients with metastatic melanoma in a Phase 3 clinical trial.

Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/7714251-amgen-imlygic-europe-appr...

IMLYGIC EU Product Image
IMLYGIC is derived from the herpes simplex type 1 virus (HSV-1) , commonly called the cold sore virus. IMLYGIC has been modified to replicate within tumors and to produce the immune stimulatory protein human granulocyte-macrophage colony-stimulating factor (GM-CSF). Administered via intralesional injection, IMLYGIC is designed to cause the death of tumor cells and initiate an anti-tumor immune response.

"As the first oncolytic immunotherapy authorized in the European Union, the approval of IMLYGIC is an important milestone for this new class of drugs, bringing patients with a rare and deadly form of skin cancer a much needed new treatment option," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "By igniting the body's own immune system IMLYGIC can initiate an anti-tumor immune response, providing meaningful and durable response rates in the early stage metastatic melanoma patient."

Melanoma remains a significant public health concern in the European Union (EU), with an estimated 22,000 deaths from the disease in 2012.1,2 While melanoma is curable when detected in the early stages, metastatic melanoma continues to be one of the most difficult-to-treat cancers because it is highly aggressive and complex.3 Even with recent new options in immune-oncology, a large number of patients with metastatic melanoma still do not respond to treatment.4

The European approval included a review of exploratory subgroup analyses of Study 005/05, referred to as OPTiM. The durable response rate (DRR) in patients with Stage IIIB, IIIC and IVM1a disease was 25.2 percent compared to 1.2 percent in those treated with GM-CSF. In the study, patients with Stage IIIB, IIIC and IVM1a disease achieved an overall response rate (ORR) of 40.5 percent when treated with IMLYGIC compared to 2.3 percent with GM-CSF. The median overall survival (OS) for IMLYGIC patients with Stage IIIB, IIIC and IVM1a disease was 41.1 months compared to 21.5 months for patients treated with GM-CSF. While the pivotal study was not powered to evaluate efficacy in these individual subgroups, patients with no visceral disease derived greater benefit from IMLYGIC treatment than those with more advanced disease. Due to the exploratory nature of the analysis and based on the current evidence, it has not been established that IMLYGIC is associated with an effect on OS.

The most commonly reported treatment-related adverse events were fatigue, chills, pyrexia, nausea, influenza-like illness and injection-site pain. Overall, 98 percent of these adverse reactions reported were mild or moderate in severity. The most common grade 3 or higher adverse reaction was cellulitis. No fatal treatment-related adverse events occurred.5

This approval grants a centralized marketing authorization in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.
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Source: press release, 12/18/15. http://wwwext.amgen.com/media/news-releases/2015/12/european-commission-...

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Amgen Receives CHMP Positive Opinion For IMLYGIC™ (Talimogene Laherparepvec)

IMLYGIC is First Oncolytic Immunotherapy to Demonstrate Therapeutic Benefit for Patients With Advanced Melanoma

THOUSAND OAKS, Calif., Oct. 23, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending that IMLYGIC™ (talimogene laherparepvec) be granted approval for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. If approved by the European Commission, IMLYGIC would be the first in a class of novel agents known as oncolytic immunotherapies.

IMLYGIC, administered via intralesional injection, is designed to cause the death of tumor cells and to initiate an anti-tumor immune response.

"We are pleased that IMLYGIC has received a positive opinion from the CHMP, and if approved by the European Commission, we look forward to continuing to work with European regulatory authorities to bring this innovative therapy to patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Metastatic melanoma continues to be one of the most difficult-to-treat cancers, often requiring the use of multiple treatment modalities. Despite recent advances, the five-year survival rate for patients who cannot be cured with surgery remains unacceptably low, demonstrating the critical need for additional approaches to control this disease."

The positive CHMP opinion was based on a global, randomized, open-label Phase 3 trial evaluating the safety and efficacy of IMLYGIC in patients with Stage IIIB, IIIC or IV melanoma when resection was not recommended compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). In the 436-patient study, IMLYGIC significantly improved durable response rate (DRR), the primary endpoint of the trial, in the intent-to-treat population. DRR is defined as the percent of patients with complete response (CR) or partial response (PR) maintained continuously for a minimum of six months. A key secondary endpoint was overall survival (OS). The positive CHMP opinion reflects subgroup analyses where the effect on OS was largest in patients with unresectable melanoma that has not spread beyond the skin or lymph nodes.

The most commonly reported treatment-related adverse events were fatigue, chills, pyrexia, nausea, influenza-like illness and injection-site pain. Overall, 98 percent of these adverse reactions reported were mild or moderate in severity. The most common grade 3 or higher adverse reaction was cellulitis.

Melanoma is a type of skin cancer that is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for providing the pigment to skin.1 Melanoma is the most aggressive and serious form of skin cancer, and remains a significant public health concern in the European Union (EU).2,3 In 2012, it was estimated that there were 56,000 new cases of melanoma in France, Italy, Spain, Germany and the U.K. causing nearly 9,500 deaths.4,5

Following this CHMP opinion, Amgen expects a decision on the Marketing Authorization from the European Commission in the coming months. IMLYGIC is also under review by the U.S. Food and Drug Administration.
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Source: press release, 10/23/15. http://wwwext.amgen.com/media/news-releases/2015/10/amgen-receives-chmp-...

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