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The FDA has given mobocertinib expedited approval for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

September 2021: The FDA granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals, Inc.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) ...

The FDA has approved zanubrutinib for the treatment of Waldenstrom’s macroglobulinemia

September 2021: For adult patients with Waldenström's macroglobulinemia, the FDA has approved zanubrutinib (Brukinsa, BeiGene) (WM).In ASPEN (NCT03053440), zanubrutinib was compared to ibrutinib in p...

Ivosidenib has been approved by the FDA for advanced or metastatic cholangiocarcinoma

Sept 19, 2021: The Food and Drug Administration approved Ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma...

TECARTUS (brexucabtagene autoleucel) – CAR T treatment for relapsed or refractory mantle cell lymphoma

July 25, 2021: Kite, a Gilead Company (Nasdaq: GILD), today announced that the FDA has granted TecartusTM (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen re...

Nivolumab has been approved by the FDA for use as an adjuvant treatment for urothelial carcinoma

August 2021: Nivolumab (Opdivo, Bristol-Myers Squibb Co.) has been approved by the Food and Drug Administration for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high ri...

The FDA has approved the combination of lenvatinib and pembrolizumab for advanced renal cell carcinoma

August 2021: The combination of lenvatinib (Lenvima, Eisai) and pembrolizumab (Keytruda, Merck) has been approved by the Food and Drug Administration for the first-line treatment of adult patients wit...

Pembrolizumab has been approved by the FDA for high-risk early-stage triple-negative breast cancer

August 2021: Pembrolizumab (Keytruda, Merck) was approved by the FDA for high-risk, early-stage triple-negative breast cancer (TNBC) as a neoadjuvant treatment in combination with chemotherapy, and la...

Pembrolizumab and lenvatinib have been approved by the FDA for advanced endometrial cancer

August 2021: Pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) has been approved by the Food and Drug Administration for patients with advanced endometrial carcinoma that...

Daratumumab and hyaluronidase-fihj plus pomalidomide and dexamethasone have been approved by the FDA for the treatment of multiple myeloma

August 2021: Daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) have been approved by the Food and Drug Administration in combination with pomalidomide and dexamethasone for a...

The FDA has given enfortumab vedotin-ejfv approval for the treatment of locally advanced or metastatic urothelial carcinoma

August 2021: Enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor combination, has been approved by the Food and Drug Administration for a...

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