European Medicines Agency recommends CAR T-cell approvals

 

The European Medicines Agency (EMA) has recommended a handful of hematology medications for approval, including two chimeric antigen receptor (CAR) T-cell therapies.

All of the drugs must next be approved by the European Commission in order to be marketed to patients throughout Europe.

At the end of June, the EMA’s Committee for Medicinal Products for Human Use recommended granting marketing authorization to Europe’s first two CAR T-cell therapies: tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta).

Courtesy Novartis

Tisagenlecleucel would be authorized for the treatment of pediatric and young adult patients with B-cell acute lymphoblastic leukemia that is relapsed or refractory, and in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Axicabtagene would be authorized for treatment of DLBCL and primary mediastinal large B-cell lymphoma (PMBCL) after two or more lines of systemic therapy. Similar indications have already been approved for these therapies in the United States.

The EMA approval recommendations come with risk management measures to address the potential for cytokine release syndrome with both of these treatments. Drug makers must use a patient registry to monitor the long-term safety and efficacy of the therapies.

The EMA is also recommending approval of caplacizumab for acquired thrombotic thrombocytopenic purpura, vonicog alfa for the treatment of von Willebrand disease, and daunorubicin/cytarabine for the treatment of acute myeloid leukemia.

[email protected]

 

The European Medicines Agency (EMA) has recommended a handful of hematology medications for approval, including two chimeric antigen receptor (CAR) T-cell therapies.

All of the drugs must next be approved by the European Commission in order to be marketed to patients throughout Europe.

At the end of June, the EMA’s Committee for Medicinal Products for Human Use recommended granting marketing authorization to Europe’s first two CAR T-cell therapies: tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta).

Courtesy Novartis

Tisagenlecleucel would be authorized for the treatment of pediatric and young adult patients with B-cell acute lymphoblastic leukemia that is relapsed or refractory, and in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Axicabtagene would be authorized for treatment of DLBCL and primary mediastinal large B-cell lymphoma (PMBCL) after two or more lines of systemic therapy. Similar indications have already been approved for these therapies in the United States.

The EMA approval recommendations come with risk management measures to address the potential for cytokine release syndrome with both of these treatments. Drug makers must use a patient registry to monitor the long-term safety and efficacy of the therapies.

The EMA is also recommending approval of caplacizumab for acquired thrombotic thrombocytopenic purpura, vonicog alfa for the treatment of von Willebrand disease, and daunorubicin/cytarabine for the treatment of acute myeloid leukemia.

[email protected]

 

The European Medicines Agency (EMA) has recommended a handful of hematology medications for approval, including two chimeric antigen receptor (CAR) T-cell therapies.

All of the drugs must next be approved by the European Commission in order to be marketed to patients throughout Europe.

At the end of June, the EMA’s Committee for Medicinal Products for Human Use recommended granting marketing authorization to Europe’s first two CAR T-cell therapies: tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta).

Courtesy Novartis

Tisagenlecleucel would be authorized for the treatment of pediatric and young adult patients with B-cell acute lymphoblastic leukemia that is relapsed or refractory, and in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Axicabtagene would be authorized for treatment of DLBCL and primary mediastinal large B-cell lymphoma (PMBCL) after two or more lines of systemic therapy. Similar indications have already been approved for these therapies in the United States.

The EMA approval recommendations come with risk management measures to address the potential for cytokine release syndrome with both of these treatments. Drug makers must use a patient registry to monitor the long-term safety and efficacy of the therapies.

The EMA is also recommending approval of caplacizumab for acquired thrombotic thrombocytopenic purpura, vonicog alfa for the treatment of von Willebrand disease, and daunorubicin/cytarabine for the treatment of acute myeloid leukemia.

[email protected]