DrugsNews.net

Drugs Xagena

Xagena Mappa
Xagena Newsletter
OncologiaMedica.net
Mediexplorer.it

Revlimid for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant


The European Commission ( EC ) has approved Revlimid ( Lenalidomide ) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

The Revlimid Marketing Authorisation has been updated to include this new indication in multiple myeloma, building upon the already approved indication of Revlimid in combination with Dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

Multiple myeloma is a persistent and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system. It is a rare but deadly disease: around 38,900 people were newly diagnosed with multiple myeloma in Europe in 2012, and 24,300 people died from the disease in the same year.
On average, multiple myeloma is diagnosed in people 65-74 years of age, and the majority of newly diagnosed patients may not be eligible for more aggressive treatment options such as high-dose chemotherapy with stem cell transplant.

The EC decision in newly diagnosed multiple myeloma was based on the results of two pivotal studies: MM-020 ( also known as the FIRST trial ) and MM-015.

The FIRST study, MM-020, was one of the largest phase III, multi-centre, open-label, randomised studies in patients newly diagnosed with multiple myeloma and not eligible for stem cell transplantation, including 1,623 patients.
It compared Lenalidomide plus Dexamethasone administered in 28-day cycles until disease progression ( Rd ), with Lenalidomide plus Dexamethasone for 72 weeks ( 18 cycles; Rd18 ) and Melphalan – Prednisone - Thalidomide ( MPT ) for 72 weeks.
Progression-free survival ( PFS; study primary endpoint ) was significantly improved in patients treated continuously with Lenalidomide plus Dexamethasone, compared with those receiving MPT ( primary comparison, p less than 0.0001 ) or Rd18 ( p less than 0.0001 ).
Median overall survival ( OS ) in patients receiving Lenalidomide plus Dexamethasone continuous therapy was 58.9 months, vs 48.5 months for patients treated with MPT ( hazard ratio, HR=0.75; 95% CI 0.62, 0.90 ), based on a March 3, 2014 interim overall survival analysis.
The numbers of patients experiencing any grade 3 or 4 adverse event were similar in each group. The most frequent grade 3 or 4 adverse events were neutropenia, anaemia and infections.

MM-015 was a multi-centre, randomised, double-blind, placebo-controlled phase III study of 459 patients that compared Melphalan – Prednisone - Lenalidomide induction followed by Lenalidomide maintenance ( MPR-R ) with Melphalan – Prednisone - Lenalidomide ( MPR ) or Melphalan - Prednisone (MP) followed by placebo in patients 65 years or older with newly diagnosed multiple myeloma.
Progression-free survival ( PFS; study primary endpoint ) was significantly improved in patients treated with MPR-R when compared with MPR and MP ( p less than 0.001 for comparisons of MPR-R over MPR and MP ).
In the MM-015 study, overall survival was not significantly improved when compared across any treatment arm.
During induction, the most frequent adverse events were hematologic ( including neutropenia, thrombocytopenia, and anaemia ).
During the maintenance phase, the incidence of new or worsened grade 3 or 4 adverse events was low ( 0 to 6% ).

Source: Celgene, 2015

XagenaMedicine_2015



Indietro