FDA has approved Loqtorz (toripalimab-tpzi) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma.
AnHeart Therapeutics has entered into an exclusive license agreement with Nippon Kayaku Co., Ltd to market and distribute AnHeart’s lead investigational therapy, taletrectinib, in Japan.
FDA has approved Tibsovo (ivosidenib) for adult patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.
FDA has approved Keytruda (pembrolizumab) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer.
FDA approved nivolumab (Opdivo) for the adjuvant treatment of completely resected stage 2B/C melanoma in patients 12 years and older.
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.
