The European Commission approved Keytruda (pembrolizumab) as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Keytruda (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1.
The European Commission approved Adcetris (brentuximab vedotin) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ stage 3 Hodgkin lymphoma.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval a Type II variation for Rubraca (rucaparib), as a first-line maintenance treatment for all women with advanced ovarian cancer regardless of their BRCA mutation status, who have responded to first-line platinum-based chemotherapy.
FDA approved Braftovi (encorafenib) with Mektovi (binimetinib) for adult patients with metastatic non-small cell lung cancer with a BRAF V600E mutation, as detected by an FDA-approved test.
Shasqi, Inc. and Johnson & Johnson Enterprise Innovation Inc. have expanded their ongoing research collaboration.
FirstLook Lung, a blood test that offers a convenient, accurate, and personalized result by determining the likelihood of detecting lung cancer through low-dose CT with a negative predictive value of 99.7%, was commercially introduced.
FDA has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers.
FDA has accepted for priority review the Biologics License Application for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies.
FDA proposed a rule seeking to amend FDA’s regulations to make explicit that in vitro diagnostic products are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.
