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Genmab's Darzalex secures CHMP recommendation in Europe for front-line multiple myeloma

The Committee for Medicinal Products for Human Use (CHMP), an advisory panel for the European Medicines Agency, has given its recommendation to Genmab’s Darzalex in combination with Bortezomib, Thalidomide and Dexamethasone as a front-line treatment for multiple myeloma (MM) in the European Union.

The indication in question relates to newly diagnosed MM patients who are eligible for autologous stem cell transplant (ASCT).

Janssen's Darzalex combo shows strong overall survival benefit at ASH 2019

Janssen has unveiled new Phase 3 data on the efficacy of Darzalex (daratumumab) when combined with bortezomib, melphalan and prednisone (D-VMP) in the treatment of newly diagnosed, transplant-ineligible multiple myeloma at the 2019 American Society of Hematology (ASH) Annual Meeting in Orlando.

In a pre-specified interim analysis conducted after a median follow-up of over three years, the Darzalex combo registered an estimated overall survival rate of 75% compared to 62% for bortezomib, melphalan and prednisone (VMP) alone.

European Commission approves Genmab's Darzalex combo in newly diagnosed multiple myeloma

Genmab’s Darzalex (daratumumab) has secured approval from the European Commission and is now authorised in Europe for the treatment of newly diagnosed multiple myeloma when used in combination with lenalidomide and dexamethasone, it has emerged.

The approval covers adult patients with condition who are ineligible for autologous stem cell transplant (ASCT), and delivers on the recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on October, just a month prior.

FDA approves Genmab's Darzalex combo in newly diagnosed multiple myeloma

Genmab’s CD38 inhibitor Darzalex (daratumumab) has been awarded marketing authorisation from the FDA in combination with bortezomib, thalidomide and dexamethasone (VTd) in the treatment of newly diagnosed multiple myeloma (MM) in patients who are eligible for autologous stem cell transplant (ASCT), it has emerged.

The decision was made via the US regulator’s Priority Review pathway and based on Phase 3 data supporting the efficacy of the Darzalex combo in 1,085 newly diagnosed, previously untreated symptomatic MM patients eligible for ASCT

Amgen's Kyprolis + Darzalex combo shows progression-free survival benefit in multiple myeloma

Amgen has revealed new Phase 3 data for the combination of Kyprolis (carfilzomib) and Darzalex (daratumumab) in addition to the steroid dexamethasone, showing that the combo met its primary endpoint of progression-free survival (PFS) in the treatment of multiple myeloma (MM) compared to Kyprolis and dexamethasone alone.

The findings showed that the three-drug regimen reduced the risk of progression or death in patients with relapsed or refractory MM by 37% compared to the two-drug combination.

Janssen's Darzalex combo approved by FDA in transplant-ineligible multiple myeloma patients

Janssen’s Darzalex (daratumumab) has secured FDA approval in combination with lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma in patients who are not eligible for autologous stem cell transplant (ASCT), the company has confirmed.

The approval, which was awarded through the US regulator’s Real-Time Oncology Review pilot programme, was based on Phase 3 data which demonstrated that, at a median follow-up of 28 months after initial treatment, the combo “significantly reduced” the risk of disease progression or death by 44% compared to lenalidomide a

Darzalex combo makes strong Phase 3 showing in multiple myeloma

Janssen joined its contemporaries at the 55th American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in the release of new data in the field of new cancer treatments.

At the event, the company lifted the curtain on Phase 3 study findings for Darzalex (daratumumab) plus bortezomib, thalidomide and dexamethasone (VTd) before and after autologous stem cell transplantation (ASCT) in the treatment of newly diagnosed multiple myeloma.

Janssen presents strong Phase 3 showing for Darzalex in multiple myeloma subgroup

Janssen has lifted the curtain on new Phase 3 data for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (Rd), showing that the combo demonstrated a “significant increase in progression-free survival (PFS)” in the treatment of newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).

After a median follow-up period of 28 months, the Darzalex/Rd combo demonstrated a reduction of 44% in the risk of disease progression or death, while median PFS was not reached, compared to 31.9 months with Rd alone.

NICE recommends Janssen's Darzalex myeloma combo

Britain’s cost effectiveness body NICE have recommended Janssen Pharmaceutical’s Darzalex in combination with Velcade and dexamethasone (DVd), for use within the cancer drugs fund as an option for treating relapsed multiple myeloma in people who have had one previous treatment.

Darzalex “significantly reduces” disease progression and death in multiple myeloma at ASH 2018

Janssen has taken the opportunity at the American Society of Hematology (ASH) Annual Meeting 2018 to unveil new Phase 3 data for its combination of Darzalex (daratumumab) alongside lenalidomide and dexamethasone (Rd) in the treatment of newly diagnosed multiple myeloma in patients who are ineligible for autologous stem cell transplant (ASCT).

The findings showed that the combo “significantly reduced” the risk of disease progression or death; at a median follow-up of 28 months, patients experienced a reduction of 44% compared to Rd alone.

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