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CT103A, CAR T-cell Therapy, has been designated as an orphan drug by the FDA

Feb 2023: The FDA has granted orphan drug status to CT103A, an experimental CAR T-cell therapy being developed by IASO Biotherapeutics and Innovent Biologics to treat relapsed or refractory multiple...

CAR T-cell treatment from IASO Biotherapeutics receives new FDA approval

Feb 2023: IASO Biotherapeutics' investigational CAR T-cell therapy for relapsed or refractory multiple myeloma (RRMM), CT103A, has received fast track and regenerative medicine advanced therapy desig...

Dostarlimab-gxly is approved by FDA for dMMR endometrial cancer

Feb 2023: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) was given FDA approval to treat adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progr...

Sacituzumab govitecan-hziy is approved by FDA for HR-positive breast cancer

Feb 2023: The Food and Drug Administration (FDA) has approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for people with hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+...

Elacestrant is approved by FDA for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

In February 2023, the Food and Drug Administration (FDA) approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for women or men over 50 who have advanced or metastatic breast cancer and are ER-...

Accelerated approval is granted by FDA to pirtobrutinib for relapsed or refractory mantle cell lymphoma

Feb 2023: Accelerated approval is granted by FDA to pirtobrutinib (Jaypirca, Eli Lilly and Company) for relapsed or refractory mantle cell lymphoma. In BRUIN (NCT03740529), an open-label, multicente...

Pembrolizumab is approved by FDA as adjuvant treatment for non-small cell lung cancer

Feb 2023: For stage IB (T2a 4 cm), stage II, or stage IIIA non-small cell lung cancer, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) as adjuvant therapy after resect...

Zanubrutinib is approved by FDA for chronic lymphocytic leukemia or small lymphocytic lymphoma

Feb 2023: Zanubrutinib (Brukinsa, BeiGene USA, Inc.) is approved by FDA for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). SEQUOIA was used to assess effectiveness in CLL/...

Accelerated approval is granted by FDA to tucatinib with trastuzumab for colorectal cancer

In February 2023, the Food and Drug Administration (FDA) sped up the approval of tucatinib (Tukysa, Seagen Inc.) and trastuzumab for the treatment of RAS wild-type HER2-positive colorectal cancer tha...

Focal HIFU therapy in prostate cancer

  What does local prostate cancer mean? In Liv Hospital Urology Clinic, HIFU is applied as the primary treatment approach in localized prostate cancer, that is, at the stage where the entire cancer ...

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