The U.S. Food and Drug Admin­istra­tion (FDA) has approved the addi­tion of a once-weekly dosing regi­men to the official pre­scrib­ing in­­for­ma­tion for Kyprolis.

In addi­tion, the FDA approved revisions in the pre­scrib­ing in­­for­ma­tion related to two safety issues: the risk of heart-related side effects due to Kyprolis, and the risk of birth defects or miscarriage in women taking or exposed to Kyprolis during preg­nancy.

The once-weekly dosing of Kyprolis is approved for use in com­bi­na­tion with dexa­meth­a­sone (Decadron) in multiple myeloma patients who have re­lapsed after one to three prior lines of …

Silver Spring, MD (Press Release) – Based on data from two recently halted clin­i­cal trials, the U.S. Food and Drug Admin­istra­tion today is issuing this state­ment to inform the public, health care professionals, and on­col­ogy clin­i­cal investigators about the risks asso­ci­ated with the use of KEYTRUDA® (pem­bro­lizu­mab) in com­bi­na­tion with dexa­meth­a­sone and an immuno­modu­la­tory agent (lena­lido­mide or poma­lido­mide) for the treat­ment of patients with multiple myeloma. KEYTRUDA® (pem­bro­lizu­mab) is not approved for treat­ment of multiple myeloma.

The FDA state­ment is based on review of data from two clin­i­cal trials (KEYNOTE-183 and KEYNOTE-185) eval­u­ating …

Silver Spring, MD (Press Release) – The U.S. Food and Drug Admin­istra­tion today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with addi­tional kidney or lung ab­nor­mal­i­ties after they receive a stem cell trans­plant from blood or bone marrow called hematopoietic stem cell trans­plan­ta­tion (HSCT). This is the first FDA-approved ther­apy for treat­ment of severe hepatic VOD, a rare and life-threatening liver con­di­tion.

HSCT is a procedure per­formed in some patients to treat certain blood or bone marrow cancers. Immediately before an HSCT procedure, a …

The United States Food and Drug Admin­istra­tion (FDA) has approved elotuzumab for the treat­ment of mul­ti­ple myeloma.

The drug will be sold under the brand name Empliciti, and it will be mar­keted by the U.S. pharma­ceu­tical com­pany Bristol-Myers Squibb. The com­pany said in a press re­lease issued this Monday that it will begin shipping Empliciti “within the next 48 hours.”

Empliciti’s ap­prov­al is for use in com­bi­na­tion with Revlimid (lena­lido­mide) and dexamethasone (Decadron) in mul­ti­ple myeloma patients who have re­ceived one to three prior ther­a­pies.

There …

Silver Spring, MD (Press Release) – Today the U.S. Food and Drug Admin­istra­tion granted ap­prov­al for Empliciti (elo­tuzu­mab) in com­bi­na­tion with two other ther­a­pies to treat people with mul­ti­ple myeloma who have re­ceived one to three prior medi­ca­tions.

Multiple myeloma is a form of blood cancer that oc­curs in in­fec­tion-fighting plasma cells (a type of white blood cell) found in the bone mar­row. These can­cer­ous cells multiply, pro­duce an ab­nor­mal pro­tein and push out other healthy blood cells from the bone mar­row. This dis­ease may re­­sult in a weakened im­mune sys­tem, and …

Die US-Bundesbehörde zur Überwachung von Nahrungs- und Arzneimitteln (FDA) hat Daratumumab für die Behandlung des multiplen Myeloms zugelassen. Das Medikament wird unter dem Markennamen Darzalex auf den Markt gebracht und voraussichtlich innerhalb von zwei Wochen in den US-amerikanischen Behandlungszentren und Arztpraxen verfügbar sein.

Die FDA hat Darzalex für die Anwendung bei Myelompatienten zugelassen, die vorher sowohl mit Immunmodulatoren als auch Proteasomenhemmstoffen behandelt worden sind. Immunmodulatorische Medikamente umfassen Revlimid (Lenalidomid), Thalidomid und Pomalyst (Pomalidomid, Imnovid). Medikamente der Proteasomenhemmstoffklasse schließen Velcade (Bortezomib) und Kyprolis (Carfilzomib) ein.

Die FDA-Zulassung von Darzalex ist genauer gesagt für …

The United States Food and Drug Admin­istra­tion (FDA) has approved ixazomib for the treat­ment of multiple myeloma.

The drug will be marketed under the brand name Ninlaro. It should be avail­able in U.S. pharmacies by the middle of next month, according to a spokesperson from Takeda Oncology, the com­pany that developed Ninlaro and will be mar­ket­ing it globally.

Ninlaro is the second new multiple myeloma ther­apy approved by the FDA this week. The agency on Monday announced the approval of Darzalex (dara­tu­mu­mab) for the treat­ment of myeloma …