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Mosunetuzumab-axgb is granted accelerated approval for relapsed or refractory follicular lymphoma

Jan 2023: Mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), a bispecific CD20-directed CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma (FL) following two or more ro...

First adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer is approved by FDA

Jan 2023: The drug nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals) has been approved by the Food and Drug Administration for adult patients with high-risk, unresponsive non-muscle...

Adagrasib gets accelerated approval for KRAS G12C-mutated NSCLC

Jan 2023: Adagrasib (Krazati, Mirati Therapeutics, Inc.), a RAS GTPase family inhibitor, was given accelerated approval by the Food and Drug Administration (FDA) for adult patients with KRAS G12C-muta...

Atezolizumab is approved by FDA for alveolar soft tissue sarcoma

Dec 2022: Atezolizumab (Tecentriq, Genentech, Inc.) has been approved by the Food and Drug Administration (FDA) for adult and paediatric patients with unresectable or metastatic alveolar soft par...

Olutasidenib is approved by FDA for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation

Dec 2022: Olutasidenib (Rezlidhia) capsules were approved by the Food and Drug Administration (FDA) for adult patients with relapsed or resistant acute myeloid leukaemia (AML) who have a suscepti...

New dosing regimen for asparaginase erwinia chrysanthemi (recombinant) is approved by FDA

Dec 2022: A new Monday-Wednesday-Friday dosing schedule for asparaginase erwinia chrysanthemi (recombinant)-rywn has been approved by the Food and Drug Administration (Rylaze, Jazz Pharmaceuticals). P...

Mirvetuximab soravtansine-gynx is granted accelerated approval for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer

November 2022: For adult patients who have had one to three prior systemic treatment regimens and have folate receptor alpha (FR) positive, platinum-resistant epithelial ovarian, fallopian tube, or pr...

Tremelimumab is approved by FDA in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer

November 2022: The combination of tremelimumab (Imjudo, AstraZeneca Pharmaceuticals), durvalumab (Imfinzi, AstraZeneca Pharmaceuticals), and platinum-based chemotherapy was approved by the Food and Dr...

Brentuximab vedotin is approved by FDA in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma

November 2022: The combination of doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide with brentuximab vedotin (Adcetris, Seagen, Inc.) has been approved by the Food and Drug Adminis...

Cemiplimab-rwlc is approved by FDA in combination with platinum-based chemotherapy for non-small cell lung cancer

November 2022: The combination of cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) and platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) without...

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