GMAN Newsletter February 2017

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Use Your Social Media to Support GMANs International Myeloma Action Day March 30, 2017

Take action! And inspire other to take action, too! On March 30, the International Myeloma Action Day is an opportunity to spread the word among patients, physicians, and decision-makers to help raise awareness and education about myeloma. Update your social media with Myeloma Action Day graphics and use the hashtag #GMANmad17, and apply the tools and templates available HEREto your activities as needed. When you translate and customize these materials, and when you tweet about how you are raising the profile of myeloma, please share the information with us so we can further support your efforts!

Broadening of marketing authorizations in the EU, reimbursement recommendation in Canada

In January, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a change to the terms of the marketing authorization for Revlimid (lenalidomide). In February, the European Commission approved Revlimid as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. This new indication expands upon the existing myeloma indications as combination therapy for the treatment of those not eligible for transplant who are newly diagnosed, or have received at least one prior therapy. The U.S. Food and Drug Administration (FDA) has also expanded the indication for Revlimid. Revlimid is the first and only licensed maintenance treatment available after autologous transplant.

In February, the CHMP issued a positive opinion recommending broadening the existing marketing authorization for Darzalex (daratumumab) in the European Union for relapsed or refractory multiple myeloma. The recommendation is for the use of daratumumab in combination with lenalidomide plus dexamethasone, or bortezomib plus dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The CHMP opinion was based on data from two phase III clinical trials, CASTOR and POLLUX. The final decision from the European Commission expected in the coming months. A CHMP opinion is one of the final steps in the regulatory process of the EMA. A final decision by the European Commission is anticipated within two months.

In Canada, the pCODR Expert Review Committee (pERC) has recommended reimbursement of Kyprolis (carfilzomib) in combination with dexamethasone for patients with relapsed myeloma with a good performance status who have received 1 to 3 prior treatments, on the condition that the cost-effectiveness be improved to an acceptable level. Registered clinicians and patient advocacy groups, including Myeloma Canada, that provided input to the submission are invited to provide feedback on the initial recommendation. The final recommendation will be issued in March.

A small clinical trial in Switzerland shows efficacy of nelfinavir as Velcade-sensitizing drug

One of the most interesting stories in new drugs for myeloma came from a small Swiss study of the anti-HIV drug nelfinavir in combination with Velcade (bortezomib) plus dexamethasone for patients with advanced myeloma who are non-responsive to the proteasome inhibitor. The results among the 34 patients treated were stunning: an overall response rate (50% or greater reduction in monoclonal protein) of 65%; for patients with high-risk cytogenetic abnormalities, a surprising 77%; for patients who had had five or more prior lines of therapy, 61%. This study is ongoing at 12 centers throughout Switzerland, but it is now fully accrued and no longer recruiting participants. The Swiss Group for Clinical Cancer Research is also conducting an ongoing study in both Switzerland and Italy of nelfinavir in combination with Revlimid (lenalidomide) plus dexamethasone in progressive myeloma.

 

Two selinexor clinical trials to become available for enrollment at centers in 17 countries in Europe

The selinexor STORM clinical trial, where a number of arms of different therapies are added to selinexor, is expanding to enroll additional penta-refractory myeloma patients. Five new centers in Europe are joining this study in Austria, Belgium, France, Germany, and Greece. These European centers are expected to start enrolling in May or June 2017. The aim of the study is to demonstrate benefit among patients refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide, plus either daratumumab or isatuximab.

The BOSTON clinical trial is based on one very successful arm of the STOMP trial in which selinexor + bortezomib + dexamethasone was given to patients who had 1-3 prior lines of therapy. This randomized trial compares selinexor + bortezomib + dexamethasone versus bortezomib + dexamethasone. It will open in 17 countries in Eastern and Western Europe in May, June, and July 2017.

Publication Update

Two new translations of the IMF Patient Handbook are available in Dutch and Swedish!


We Thank Our Sponsors: Amgen, Bristol-Myers Squibb, Celgene, Genentech, and Takeda.

Events in Madrid International Patient Seminars

June 17-19
GMAN Annual Summit

June 17-19
IMWG Annual Summit

June 22-25
EHA Annual Summit

March 17-18
IMF Patient & Family Seminar Stockholm, Sweden

May 6
IMF Patient & Family Seminar La Hulpe, Belgium

June 10
IMF Patient & Family Seminar Paris, France

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