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Ruxolitinib is approved for chronic graft-versus-host disease

October 2021: After failure of one or two lines of systemic therapy, the Food and Drug Administration approved ruxolitinib (Jakafi, Incyte Corp.) for chronic graft-versus-host...

Tisotumab forvedotin-tftv is approved for recurrent or metastatic cervical cancer

October 2021: The FDA has given tisotumab vedotin-tftv (Tivdak, Seagen Inc.), a tissue factor-directed antibody and microtubule inhibitor combination, rapid approval for adult patients with...

Cabozantinib is approved for differentiated thyroid cancer

October 2021: Cabozantinib (Cabometyx, Exelixis, Inc.) has been approved by the Food and Drug Administration for adult and paediatric patients 12 years of age and...

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...

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...

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...

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...

Dostarlimab-gxly receives accelerated approval from the FDA for dMMR advanced solid tumours

August 2021: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) was given accelerated approval by the Food and Drug Administration for adult patients with mismatch repair deficient (dMMR) recurrent...

Belzutifan has been approved by the FDA for malignancies linked to von Hippel-Lindau disease

August 2021: Belzutifan (Welireg, Merck), a hypoxia-inducible factor inhibitor, has been approved by the Food and Drug Administration for adult patients with von Hippel-Lindau disease...

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...

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,...

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