Keytruda has received an expanded label approval from FDA as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) was approved by FDA as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment.
The European Commission has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.
The European Commission has approved Keytruda in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10).
The European Commission has approved the PD-1 inhibitor Libtayo (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations.
The European Commission has approved the PD-1 inhibitor Libtayo (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended granting Conditional Marketing Authorization for Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
The Committee for Medicinal Products for Human Use of the European Medicines Agency as recommended approval of Opdivo (nivolumab) for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.
The European Commission has approved Onureg (azacitidine tablets)as the first and only once-daily, frontline oral maintenance therapy in the EU for patients with a broad range of acute myeloid leukemia subtypes.
FDA has approved Ayvakit (avapritinib) for adult patients with advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemia.
