Amgen Gets CHMP’s Recognition to Extend Kyropolis for Relapsed Multiple Myeloma Treatment

Amgen, a biotechnology company specializing in human therapeutics, recently announced that the European Medicines Agency’s Committee for Medicinal Product for Human Use or CHMP offered a favorable response to extend the indications of Kyropolis treatment.  The committee recommends the use of Kyropolis for the treatment of relapsed cases of Multiple Myeloma.

Kyropolis will be combined with dexamethasone, a form of corticosteroid, for adult patients suffering from this condition.  The target patients are those who had one prior therapy for multiple myeloma.

Amgens EVP of R& D, Sean Harper shared that the results of the first comparative head-to-head study on the two proteasome inhibitors for relapsed multiple myeloma, showed that when Kyropolis was combined with dexamethasone, the progression-free survival of the patients was doubled as compared with the standard treatment which is the Velcade.

Harper also extends his gratitude to CHMP for recognizing the potential indication of Kyropolis.  CHMP’s positive opinion was based from the head-to-head Endeavor Trial, wherein patients with multiple myeloma who were given Kyropolis and dexamethasone achieved a superior progression free survival of 18.7 months compared with a 9.4 months in patients receiving Velcade with dexamethasone.

Velcade is used for the treatment of mantle cell lymphoma and multiple myeloma. While dexamethasone is a medication used to relieve signs of inflammation like redness, swelling, heat and pain. This corticosteroid is also used for the treatment of certain types of cancer.

Potential Side Effects 

Amgen reported that based on their clinical trials, the most common side effects of this drug that are observed in more than 20% of the patients include anemia, dyspnea, diarrhea, nausea, cough, thrombocytopenia, peripheral edema and respiratory tract infection.

The positive recognition of CHMP will now be a subject of review by the European Commission.  Amgen believes that if they will be able to get an approval, the marketing will include Kyropolis plus dexamethasone which will be distributed to the 28 members of European Union including Norway, Iceland and Lichtenstein.

Last Friday when the news emerged regarding CHMP’s positive review on Kyropolis, the stock of Amgen increase up to 0.59% higher.

Understanding the complicated case of Multiple Myeloma 

According to the American Cancer Society, Multiple Myeloma is a cancer formed from the malignant plasma cells.  These cells are normally found in the bone marrow and they play an important role in the immune system. A patient suffering from Multiple Myeloma, have too much production of plasma cells in the bone marrow that could lead to overcrowding which leads to outnumbering of the normal blood-forming cells.

When there’s an overgrowth of malignant plasma cells, they will produce a tumor called plasmacytoma. These tumors develop in the bone but they can also be found in other tissues, but this rarely happens. If a patient has a single plasma cell tumor it is called a solitary or isolated plasmacytoma.  If the patient has more than one plasmacytoma this is called multiple myeloma.

Targeting Rare Diseases

Amgen is known to provide medicines for rare diseases.  The positive review on Kyropolis is great news for patients suffering from multiple myeloma considering that it shows a faster treatment process as compared with the standard drug.

Hopefully, more cancer drugs will be developed in the market that will provide a more rapid treatment and recovery period for patients suffering from cancer.

Leave a Reply

Your email address will not be published. Required fields are marked *