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FDA Approves Kyprolis (carfilzomib) Once-Weekly Kd70 Regimen for Relapsed or Refractory Multiple Myeloma

FDA Approves Kyprolis (carfilzomib) Once-Weekly Kd70 Regimen for Relapsed or Refractory Multiple Myeloma

THOUSAND OAKS, Calif., Oct. 1, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for Kyprolis (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma. The approval is based on data from the Phase 3 A.R.R.O.W. trial, which demonstrated that Kyprolis administered once-weekly at 70 mg/m2 with dexamethasone achieved superior progression-free survival (PFS) and overall response rates (ORR), with a comparable safety profile, versus twice-weekly Kyprolis administered at a dose of 27 mg/m2 in combination with dexamethasone (twice-weekly Kd27). Kyprolis is not approved for twice-weekly 27 mg/m2 administration in combination with dexamethasone alone.

“In the fight against multiple myeloma, we are committed to continued evidence generation and innovation to serve patients. Kyprolis now offers patients with relapsed or refractory multiple myeloma the option of a more convenient dosing regimen that provides better outcomes with a comparable safety profile,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We’re pleased that the FDA has recognized the importance of bringing more treatment options to cancer patients more quickly through its pilot programs and proud to participate with this Kyprolis data.”

The FDA reviewed the application under its Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot programs, which aim to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. The FDA approved the application in just over one month after the final component of the application was submitted.

“While great progress has been made in the last decade, multiple myeloma remains an incurable disease characterized by a recurring pattern of remission and relapse, and it is important that patients have treatment options that meet their individual needs,” said David S. Siegel, M.D., Ph.D., chief of the Division of Multiple Myeloma at John Theurer Cancer Center at Hackensack University Medical Center. “The availability of a more convenient once-weekly dosing regimen, with superior efficacy, comparable safety, and longer duration of therapy versus the twice-weekly regimen studied in the trial could allow patients to spend more time outside of the infusion center.”

A.R.R.O.W. included 478 patients with relapsed and refractory multiple myeloma who received at least two or three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Patients in the trial treated with once-weekly Kd70 achieved a statistically significant 3.7 month improvement in PFS compared to the Kd27 twice-weekly regimen (median PFS 11.2 months for once-weekly Kd70 versus 7.6 months for twice-weekly Kd27; HR=0.69; 95 percent CI: 0.54-0.88; one-sided p=0.0014).The ORR in patients treated with once-weekly Kd70 was 62.9 percent versus 40.8 percent for those treated with twice-weekly Kd27 (p

The overall safety profiles of the two arms in A.R.R.O.W. were comparable, with no new safety risks identified in the once-weekly arm. Discontinuation rates due to adverse events were similar in the two arms. The most frequently reported treatment-emergent adverse events (greater than or equal to 20 percent) in either treatment arm were anemia, diarrhea, fatigue, hypertension, insomnia and pyrexia.

The interim data were presented during an oral session at the 54th Annual Meeting of the American Society of Clinical Oncology and simultaneously published in The Lancet Oncology.

About A.R.R.O.W.

The A.R.R.O.W. (RAndomized, Open-label, Phase 3 Study in Subjects with Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination with Dexamethasone, Comparing Once-Weekly versus Twice-weekly Carfilzomib Dosing) trial evaluated 478 patients with relapsed and refractory multiple myeloma who have received at least two but no more than three prior therapies, including bortezomib and an immunomodulatory drug. Those included in the study were randomized to receive a 30-minute infusion of once-weekly Kyprolis (20 mg/m2 on day 1 of cycle 1; 70 mg/m2 on days 8 and 15 of cycle 1; and 70 mg/m2 on days 1, 8 and 15 of subsequent cycles) with dexamethasone (40 mg) versus a 10-minute infusion of twice-weekly Kyprolis (20 mg/m2 on days 1 and 2 of cycle 1; 27 mg/m2 on days 8, 9, 15 and 16 of cycle 1; and 27 mg/m2 on days 1, 2, 8, 9, 15 and 16 of subsequent cycles) with dexamethasone (40 mg). The primary endpoint of the trial was PFS, defined as the time from randomization to disease progression or death. Secondary endpoints included ORR, overall survival, and safety and tolerability.

The trial was conducted in approximately 100 sites worldwide. For more information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT02412878.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.1 It is a rare and life-threatening disease that accounts for approximately one percent of all cancers.2,3 Worldwide, approximately 114,000 people are diagnosed with multiple myeloma each year and 80,000 patient deaths are reported on an annual basis.2

About Kyprolis (carfilzomib)

Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.4 Kyprolis has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.5 In some cells, Kyprolis can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.4,5

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

References:

  1. Jakubowiak A. Management Strategies for Relapsed/Refractory Multiple Myeloma: Current Clinical Perspectives. Seminars in Hematology. 2012; 49(3)(1),S16-S32.
  2. GLOBOCAN 2012. Global Prevalence and Incidence. Available at: http://globocan.iarc.fr/old/summary_table_pop_prev.asp?selection=224900&title=World&sex=0&window=1&sort=0&submit=%C2%A0Execute%C2%A0. Accessed on Aug. 27, 2018.
  3. American Cancer Society. About Multiple Myeloma. Available at https://www.cancer.org/content/dam/CRC/PDF/Public/8738.00.pdf. Accessed on Aug. 27, 2018.
  4. Moreau P, Richardson PG, Cavo M, et al. Proteasome Inhibitors in Multiple Myeloma: 10 Years Later. Blood. 2012; 120(5):947-959.
  5. Kortuem KM and Stewart AK. Carfilzomib. Blood. 2012; 121(6):893-897.

SOURCE Amgen

Posted: October 2018

Related Articles:

  • FDA Approves New Kyprolis (Carfilzomib) Combination Therapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma – January 21, 2016
  • FDA Approves Kyprolis (carfilzomib) for Combination Treatment of Patients with Relapsed Multiple Myeloma – July 24, 2015
  • FDA Approves Kyprolis for Patients with Advanced Multiple Myeloma – July 20, 2012
  • Onyx Pharmaceuticals’ Kyprolis Receives Positive Vote from Oncologic Drugs Advisory Committee (ODAC) – June 21, 2012
  • Onyx Pharmaceuticals to Hold Conference Call on June 20, 2012 to Discuss FDA Advisory Committee Recommendation for Kyprolis – June 19, 2012
  • Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma – April 27, 2012
  • Onyx Pharmaceuticals Announces FDA Acceptance of New Drug Application for Carfilzomib for the Treatment of Relapsed and Refractory Multiple Myeloma – November 29, 2011
  • Onyx Pharmaceuticals Submits New Drug Application for Carfilzomib in Relapsed and Refractory Multiple Myeloma – October 12, 2011
  • Onyx Pharmaceuticals Provides Status Update on Carfilzomib – October 8, 2010

Kyprolis (carfilzomib) FDA Approval History

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