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CHMP

Two CHMP recommendations for AstraZeneca: Imfinzi in first-line lung cancer, Calquence in chronic lymphocytic leukaemia

AstraZeneca has secured two new recommendations for approval of its products from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP): Imfinzi (durvalumab) and Calquence (acalabrutinib).

Imfinzi received CHMP backing for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with chemotherapy: etoposide plus either carboplatin or cisplatin. 

Positive CHMP approval for Takeda's Alunbrig in ALK+ advanced non-small lung cancer

Takeda’s Alunbrig (brigatinib) has been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), it has emerged. The committee chose to give a positive opinion for the drug as a monotherapy in the treatment of anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) in adult patients who have not previously received an ALK inhibitor.

The decision was based on Phase 3 comparing Alunbrig to crizotinib in the same indication.

Takeda's subcutaneous vedolizumab nabs CHMP nod for maintenance of ulcerative colitis and Crohn's

Takeda’s subcutaneous formulation of its gut-selective biologic vedolizumab has secured recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), it has emerged, which advocated for its use as a maintenance treatment for Moderate to severely active ulcerative colitis (UC) or Crohn’s disease (CD).

The manufacturer also revealed that it plans to offer this subcutaneous formulation in both a pre-filled syringe and a pre-filled pen.

AbbVie's Venclyxto pins down CHMP approval for treatment-naive chronic lymphocytic leukaemia

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has awarded recommendation to AbbVie’s Venclyxto (venetoclax), it has emerged, in the treatment of previously untreated chronic lymphocytic leukaemia (CLL) when combined with obinutuzumab.

Phase 3 data submitted in support of the application showed that Venclyxto displayed “superior” benefit in progression-free survival compared to the standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil, meeting the study’s primary endpoint.

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).

EMA's CHMP recommends new dosing schedule for Opdivo in melanoma

Bristol-Myers Squibb has revealed that its blockbuster immunotherapy drug Opdivo (nivolumab) has secured recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for a new dosing schedule in the adjuvant treatment of specific patients with melanoma.

The recommendation concerns adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Bayer's Vitravki poised to become first tumour-agnostic therapy in EU following CHMP recommendation

Bayer’s oral TRK inhibitor Vitrakvi (larotrectinib) could be set to become the European Union’s first drug approved in a tumour-agnostic indication after it emerged that it had secured a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The committee backed the approval of the therapy for the treatment of both adult and paediatric patients with solid tumours that a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, or whose disease is locally advanced, metastatic or where surgical resection is anticip

Janssen secures two positive CHMP opinions for Imbruvica label expansions

Janssen’s Imbruvica (ibrutinib) has racked up two positive recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), it has been revealed.

While CHMP opinions are not binding, they are usually followed when it comes to passing a final verdict on whether to approve a product for market, meaning Imbruvica could soon see its label expanded.

AZ and MSD's Lynparza secures CHMP nod in first-line BRCA-mutated ovarian cancer

AstraZeneca and MSD’s Lynparza (olaparib) has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), it has emerged, as a first-line maintenance treatment of BRCA-mutated advanced ovarian cancer.

Specifically, the recommendation covers the use of the drug as a maintenance treatment for adult patients advanced BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

CHMP recommendation for bluebird bio's gene therapy in β-thalassaemia

Massachusetts-based bluebird bio has taken a significant leap forward in its pursuit of regulatory authorisation for its first gene therapy, Zynteglo (autologous CD34+ cells encoding β-globin AT87Q gene), securing recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) ) in the treatment of transfusion-dependent β-thalassaemia (TDT).

Specifically, the recommendation referred to the treatment of the blood disorder in patients over 12 years of age who do not have a β0/β0 genotype, for whom haematopoietic stem cell (HSC

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