Global Oncology

Serplulimab is now the only anti–PD-1 monoclonal antibody approved by the MHRA for patients with extensive-stage small cell lung cancer in the first line.

CHMP issues positive opinion for isatuximab plus VRd in transplant-eligible, newly diagnosed multiple myeloma.

The EMA’s CHMP has issued a positive opinion regarding the use of subcutaneous daratumumab in high-risk smoldering myeloma.

The EMA’s CHMP has issued a positive opinion for UM171 cell therapy for patients with hematological malignancies and limited stem cell transplant options.

The European Medicines Agency’s CHMP has recommended the approval of darolutamide plus ADT in mHSPC in the European Union.

The EMA’s Committee for Medicinal Products for Human Use granted a positive opinion for nirogacestat for the treatment of patients with desmoid tumors.

The EMA’s CHMP has recommended the approval of cabozantinib for patients with pancreatic and extra-pancreatic neuroendocrine tumors.

CHMP recommended ibrutinib plus immunochemotherapy for previously untreated, transplant-eligible mantle cell lymphoma.

Adjuvant ribociclib plus endocrine therapy has gained Canadian approval for HR-positive/HER2-negative early breast cancer at high risk of recurrence.

Health Canada has approved a quizartinib-based regimen for the treatment of patients with newly diagnosed FLT3-ITD–positive acute myeloid leukemia.

The E1910 trial results showed improved OS and RFS with blinatumomab vs chemotherapy in patients with newly diagnosed BCR::ABL1-negative B ALL.

The Center for Drug Evaluation of the Chinese NMPA has accepted the marketing authorization application for pimicotinib in patients with TGCT.

Time-limited therapy with acalabrutinib plus venetoclax with or without obinutuzumab is approved in the European Union for untreated patients with CLL.

Cadonilimab plus chemotherapy with or without bevacizumab has received NMPA approval for first-line recurrent or metastatic cervical cancer.

A new drug application seeking the Chinese approval of sintilimab plus fruquintinib in second-line advanced/metastatic RCC has been accepted by the NMPA

Frontline BNT327/PM8002 plus chemotherapy was effective and safe in patients with unresectable pleural and peritoneal mesothelioma.

Brentuximab vedotin plus ECADD chemotherapy has been approved in Europe for adult patients with newly diagnosed, stage IIB to IV Hodgkin lymphoma.

The European Medicines Agency's CHMP has recommended the use of denosumab biosimilars referencing Prolia and Xgeva in all reference product indications.

Ivonescimab plus chemotherapy improved PFS vs chemotherapy alone in second- and later-line EGFR-mutated non–small cell lung cancer.

China’s NMPA approved zanidatamab for previously treated, unresectable or metastatic, HER2-positive biliary tract cancer.

Nivolumab has been approved for subcutaneous use across several adult solid tumor indications that have an existing indication for intravenous use.

The EMA’s CHMP recommended the EU approval of first-line tislelizumab plus chemotherapy for adults with recurrent or metastatic nasopharyngeal carcinoma.

CHMP backed perioperative durvalumab plus neoadjuvant chemotherapy for MIBC based on the NIAGARA trial, which showed improved EFS vs chemotherapy alone.

The EMA’s CHMP has recommended the approval of inavolisib plus palbociclib/fulvestrant in PIK3CA-mutated, ER-positive advanced breast cancer.

The EMA’s CHMP has recommended the approval of obecabtagene autoleucel for adult patients with relapsed/refractory B-ALL.