September 22, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Thousand Oaks, Calif.-based Amgen announced Friday that the U.S. Food and Drug Administration (FDA) had accepted the company’s supplemental New Drug Application (sNDA) for Kyprolis (carfilzomib) for Injection for patients with relapsed multiple myeloma. Analysts note that this is part of the company’s increased focus on diversifying its oncology drugs portfolio.
This sNDA for Kyprolis comes shortly after the FDA’s recent approval for Kyprolis in combination with Celgene Corp. (CELG)’s Revlimid (lenalidomide) and dexamethasone in relapsed multiple myeloma.
“Clinicians need a range of options and robust clinical data to make informed choices that can ideally extend the time patients live without their cancer progressing,” said Sean Harper in a statement. Harper is Amgen’s executive vice president of research and development. “The acceptance of this submission is an important next step toward providing more options for patients with relapsed multiple myeloma and we look forward to working with the FDA over the coming months.”
Amgen is facing a number of patent expirations for its older blockbuster drugs, Neulasta, Neupogen and Epotin Alfa. In 2014 those drugs made up $7.8 billion of the company’s revenue, almost 40 percent. Analysts project that by 2020, Amgen’s cancer drug revenue will drop to $5.3 billion.
Already Novartis AG ADR’s Sandoz has launched a biosimilar to Neupogen called Zarxio.
Amgen announced good news in June for its Phase III study of Vectibix (panitumumab) for chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC). The drug met is primary endpoint, which was overall survival (OS). Patients showed statistically significant improvement in OS. In 2006, the FDA approved Vectibix for the standalone treatment of metastatic colorectal cancer. In 2014, it was approved along with Folfox as a first-line therapy for a form of metastatic colorectal cancer.
In June, the company also received approval for its cholesterol drug Repatha. Analysts project that Repatha could generate $2.5 billion for Amgen in 2020.
In terms of its cancer portfolio, Amgen has 11 experimental cancer drugs in early-stage clinical trials. Five are being tested in mid-stage trials and seven in late-stage trials. The company also has several newer cancer drugs, including Xgeva, Vectibix, and Kyprolis. In 2014, they created combined revenue of $2 billion, which is expected to hit $4.7 billion by 2020.
Only last week Amgen announced a strategic collaboration deal with Monrovia, Calif.-based Xencor, Inc. (XNCR) to develop and commercialize cancer drugs and inflammatory drugs. The deal includes molecular engineering by Xencor and preclinical development for five programs proposed by Amgen that leverage various project related to T-cells and immunology. Amgen will pay Xencor $45 million upfront and up to $1.7 billion in various milestone payments.
“We are pleased to be joining forces with Xencor to expand our immuno-oncology and inflammation position by leveraging Amgen’s antibodies and Xencor’s bispecific antibody platform,” said Harper in a statement. “We are especially excited about the T cell engaging bispecific antibody directed against CD38, which complements Amgen’s BITE platform, while growing our hematology and oncology portfolio that includes two bispecific T cell engager antibodies, BLINCYTO (blinatumomab) and AMG 330, as well as Kyprolis (carfilizomib) for relapsed multiple myeloma.”
