IMiD Combination Therapies Form Backbone of Multiple Myeloma Research

Celgene Corporation  announced that nearly 30 combination studies including IMiD® compounds, REVLIMID® (lenalidomide) and POMALYST®/IMNOVID® (pomalidomide), across a range of patient segments within multiple myeloma are being presented at the 57^thAmerican Society of Hematology Annual Meeting (ASH).

In the U.S., REVLIMID in combination with dexamethasone is approved for patients with multiple myeloma and POMALYST in combination with dexamethasone is approved for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. These treatments are the subject of important investigational studies in combination with investigational and approved agents.

In the United States, REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

IBRUTINIB COMBINATION DATA SHOW PROMISE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

AbbVie announced preliminary data from the ongoing Phase 1/2b PCYC-1119 trial suggesting that the combination of ibrutinib (IMBRUVICA^®) plus carfilzomib with or without dexamethasone was well tolerated in relapsed or refractory patients with multiple myeloma (MM), with an initial objective response rate (ORR) of 62%. These data will be presented today in an oral presentation at the 57th Annual American Society of Hematology (ASH) Meeting and Exposition in Orlando, FL at 5:30 p.m. ET. IMBRUVICA is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company, and Janssen Biotech, Inc.

MM is a blood cancer that most commonly arises from B cells, a type of white blood cell (lymphocyte) that originates in the bone marrow. This year, approximately 26,850 people will be diagnosed with the disease and about 11,240 will die. 

IMBRUVICA is currently approved for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, CLL patients who have del 17p and patients with Waldenström's macroglobulinemia.  IMBRUVICA is also approved for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for the MCL indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.

Daratumumab accepted for accelerated CHMP assessment

Janssen-Cilag International NV announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted its request for an accelerated assessment of the daratumumab Marketing Authorisation Application (MAA). This acceptance follows the earlier regulatory submission of a MAA which seeks authorisation of daratumumab as a single agent for the treatment of patients with relapsed and refractory multiple myeloma and is currently pending validation by the EMA.

The CHMP grants accelerated assessment when a medicinal product is expected to be of major public health interest particularly from the point of view of therapeutic innovation. Daratumumab is an investigational, human anti-CD38 monoclonal antibody that works by binding to CD38, a signalling molecule found on the surface of multiple myeloma cells.

In doing so, daratumumab triggers the patient’s own immune system to attack the cancer cells, resulting in rapid tumour cell death through multiple immune-mediated and other mechanisms of action.

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.MM is the second most common form of blood cancer, with around 39,000 new cases in Europe in 2012. MM most commonly affects people over the age of 65 and is more common in men than in women. Daratumumab is an investigational human monoclonal antibody that binds with high affinity to the CD38 molecule, which is found on the surface of multiple myeloma cells. It is believed to induce rapid tumour cell death through multiple immune-mediated mechanisms, including complement-dependent cytotoxicity, antibody-dependent cellular phagocytosic and antibody-dependent cellular cytotoxicity, as well as via induction of apoptosis.

Novartis receives EU approval for Farydak

Novartis announced today that the European Commission has approved Farydak^® (panobinostat, previously known as LBH589) capsules, in combination with bortezomib* and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent (IMiD). The approval of Farydak marks the first time a histone deacetylase (HDAC) inhibitor with epigenetic activity is available in the European Union (EU), providing a new treatment option for patients living with multiple myeloma whose disease has progressed after standard-of-care therapy.

Multiple myeloma is a cancer of the plasma cells, a type of white blood cell present in the bone marrow, and affects approximately 84,000 people in Europe. Farydak is the first HDAC inhibitor to show efficacy in multiple myeloma. As an HDAC inhibitor, its epigenetic activity may help restore cell function in patients with multiple myeloma.

Farydak in combination with bortezomib and dexamethasone is also approved in the US, Chile and Japan for certain patients with previously treated multiple myeloma. The exact indication for Farydak varies by country. In the US, Farydak is approved in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an IMiD. Continued approval in the US may be contingent upon verification and description of clinical benefit in confirmatory trials.

 

U.S. FDA Grants Priority Review To Daratumumab

Janssen Research & Development, LLC (Janssen) announced today the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for daratumumab as a treatment for patients with multiple myeloma who are refractory to both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who have received three or more prior lines of therapy, including a PI and an IMiD. This is referred to as "double refractory" multiple myeloma, which occurs when a patient's disease has become resistant to at least two of the most commonly utilized and active classes of anti-myeloma agents.

The FDA grants Priority Review to investigational therapies that if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.[1] This designation shortens the review period to six months compared to 10 months for Standard Review. With today’s announcement, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016 to render a decision on the daratumumab application.

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells. Multiple myeloma is the third most common blood cancer in the U.S., behind only leukemia and lymphoma.[3] Approximately 26,850 new patients will be diagnosed with multiple myeloma, and approximately 11,240 people will die from the disease in the U.S. in 2015. Globally, it is estimated that 124,225 people will be diagnosed and 87,084 will die from the disease in 2015. While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections. Patients who relapse after treatment with standard therapies, including PIs or IMiDs, have poor prognoses and few treatment options.