Global

CE label expansion was granted to the Ventana PD-L1 assay for use as a companion diagnostic to identify patients with non–small cell lung cancer who are eligible for treatment with adjuvant atezolizumab.

The China National Medical Products Administration’s Center for Drug Evaluation has accepted for review a supplemental biologics application seeking the approval of tislelizumab plus chemotherapy in the first-line treatment of patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

The European Medicines Agency has accepted the marketing authorization application for the oral fixed-dose combination of decitabine and cedazuridine for the frontline treatment of adults with acute myeloid leukemia who are not candidates for standard induction chemotherapy.

The European Medicines Agency has validated a marketing authorization application for elacestrant for estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer.

The United Kingdom Medicines and Healthcare Products Regulatory Agency has extended the conditional marketing authorization of fam-trastuzumab deruxtecan-nxki for single-agent use in adult patients in Great Britain who have HER2-positive unresectable or metastatic breast cancer and have received 1 or more prior HER2-based regimens.

The European Commission has approved melphalan flufenamide for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 3 prior therapies.

The European Commission has granted an orphan medicinal product designation to INBRX-109 for use as a potential therapeutic option in patients with chondrosarcoma.

Sintilimab in combination with a bevacizumab biosimilar plus pemetrexed and cisplatin induced a progression-free survival benefit of 2.6 months compared with chemotherapy alone for patients with EGFR-mutated, locally advanced or metastatic non–small cell lung cancer, according to interim findings from the ongoing phase 3 ORIENT-31 trial.

Ropeginterferon alfa-2b produced durable complete hematologic responses without phlebotomy and showcased a consistent safety profile in Japanese patients with polycythemia vera, according to findings from a phase 2 study (NCT04182100) presented during the 2022 EHA Congress.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of the fixed-dose combination of nivolumab and relatlimab for the frontline treatment of adult and adolescents who are 12 years of age or older with advanced melanoma and a tumor cell PD-L1 expression of less than 1%.

Eltanexor has been granted a fast track designation from the FDA and an orphan medicinal product designation from the European Commission for use as a potential therapeutic option in patients with myelodysplastic syndromes.

The European Commission granted a full marketing authorization to selinexor in combination with once-weekly bortezomib and low-dose dexamethasone for the treatment of adults with multiple myeloma who have received at least 1 previous therapy.

The European Commission has approved fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received at least 1 anti–HER2-based regimen.

Pralsetinib has been approved in Hong Kong, China, for use in treatment-naïve and pretreated adult patients with RET fusion–positive, metastatic non–small cell lung cancer.

The European Commission has granted approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed/refractory follicular lymphoma after 3 or more prior lines of systemic therapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of olaparib for the adjuvant treatment of patients with germline BRCA-mutated, HER2-negative, high-risk, early breast cancer who have received neoadjuvant or adjuvant chemotherapy.

The European Commission has approved pembrolizumab for adjuvant treatment of adult and adolescent patients 12 years and older with stage IIB or IIC melanoma who have undergone a complete resection.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization for asciminib for the treatment of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who were previously treated with at least 2 TKIs.

The European Medicines Agency's Committee for Medicinal Products for Human Use has unanimously recommended full marketing authorization approval of melphalan flufenamide for patients with triple-class refractory multiple myeloma.

The European Commission has approved capmatinib as a single agent for the treatment of patients with MET exon14 skipping–altered advanced non–small cell lung cancer who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

The European Medicines Agency has verified its type II variation application to extend the indication for lisocabtagene maraleucel to include the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma, who are refractory or have relapsed within 12 months of initial therapy and are candidates for hematopoietic stem cell transplant.

The China National Medical Products Administration’s Center for Drug Evaluation granted 2 breakthrough therapy designations to repotrectinib for the treatment of patients with ROS1-positive metastatic non–small cell lung cancer.

The European Commission has approved atezolizumab for use as an adjuvant treatment following complete resection and platinum-based chemotherapy in adult patients with non–small cell lung cancer and a high risk of recurrence whose tumors do not have EGFR mutations or ALK alterations but have a PD-L1 expression of 50% or higher.

The European Commission has granted a conditional marketing authorization for mosunetuzumab for the treatment of adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 systemic therapies.

The BTK inhibitor zanubrutinib has been approved in Uruguay for the treatment of adult patients with previously treated mantle cell lymphoma, relapsed or refractory marginal zone lymphoma, and Waldenström macroglobulinemia.

The European Commission has approved the combination of polatuzumab vedotin and rituximab and cyclophosphamide, doxorubicin, and prednisone for use in adult patients with previously untreated diffuse large B-cell lymphoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use as adjuvant therapy in adult and adolescent patients aged 12 years and older with stage IIB or IIC melanoma following complete resection.

A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of adagrasib for therapeutic use in previously treated patients with non–small cell lung cancer harboring a KRAS G12C mutation.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of selinexor in combination with bortezomib and low-dose dexamethasone for use in adult patients with multiple myeloma who have previously received 1 to 3 prior lines of treatment.

The European Commission has approved the CD19-targeting chimeric antigen receptor T-cell agent tisagenlecleucel for the treatment of adults with relapsed/refractory follicular lymphoma following at least 2 lines of systemic therapy.