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FDA approved

FDA_Approved
February 7, 2023
Breast Cancer/New Drug Applications

FDA Approves Sacituzumab Govitecan-hziy for HR+/HER2- Metastatic Breast Cancer

On February 3, 2023, the U.S. Food and Drug Administration approved sacituzumab govitecan-hziy for women 18 years or older with HR+/HER2-Metastatic Breast Cancer refractory to or relapsed after at least 2, and

FDA_Approved
New Drug Applications

FDA Approves Tucatinib Plus Trastuzumab for RAS Wild-type, HER2+ Metastatic Colorectal Cancer

On January 19, 2023, the U.S. Food and Drug Administration granted accelerated approval to Tucatinib plus Trastuzumab for adult patients with RAS wild-type metastatic colon cancer with HER2-positive status as detected at a Clinical Laboratory Improvement Act (CLIA)-certified or International

January 26, 2023

FDA Approves Pembrolizumab as Adjuvant therapy for Early-stage Resectable Non-small Cell Lung Cancer

Lung Cancer/New Drug Applications

On January 26, 2023, the U.S. Food and Drug Administration approved Pembrolizumab for patients with resectable, stage IB (≥4cm)-IIIA (as per the AJCC 7th

FDA approves Elacestrant for ER-positive, HER2-negative, ESR1-Mutated Advanced or Metastatic Breast Cancer

New Drug Applications

On January 27, 2023, the U.S. Food and Drug Administration approved elacestrant for postmenopausal, non-pregnant women and adult men with advanced or metastatic ER-positive

FDA_Approved
New Drug Applications

FDA Approves Dabrafenib with Trametinib for Pediatric Patients with Low-Grade Glioma (LGG), a BRAF V600E Mutation

On March 16, 2023, the U.S. Food and Drug Administration approved dabrafenib and trametinib for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation

More
by Tiani Grosso
March 20, 2023
FDA_Approved
New Drug Applications

FDA Approves an Expanded Indication of Abemaciclib with Endocrine Therapy for Early Breast Cancer

On March 4, 2023, the U.S. Food and Drug Administration approved expanded use of adjuvant abemaciclib with endocrine therapy for adult patients with early, hormone receptor (HR)-positive, human epidermal growth factor receptor

More
by Tiani Grosso
March 7, 2023
FDA_Approved
New Drug Applications

FDA Grants Regular Approval to Dostarlimab-gxly for dMMR Endometrial Cancer

On February 9th, 2023, the U.S. Food and Drug Administration approved dostarlimab-gxly for adult patients with recurrent or advanced endometrial cancer (EC) with mismatch repair deficiency (dMMR) determined by an FDA-approved test,

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by Tiani Grosso
February 16, 2023
Hematologic Malignancies/Opinion

FDA Approves Pemigatinib in Patients with Relapsed/Refractory Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement: Finally a Treatment Option for a Challenging Disease

By Dr. Abhishek A. Mangaonkar Mayo Clinic   The phase 2 FIGHT-203 trial (NCT#03011372) studied 28 patients with relapsed/refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement. FGFR1 rearrangement should be suspected in patients who

More
by Tiani Grosso
February 7, 2023
FDA_Approved
Breast Cancer/New Drug Applications

FDA Approves Sacituzumab Govitecan-hziy for HR+/HER2- Metastatic Breast Cancer

On February 3, 2023, the U.S. Food and Drug Administration approved sacituzumab govitecan-hziy for women 18 years or older with HR+/HER2-Metastatic Breast Cancer refractory to or relapsed after at least 2, and

More
by Tiani Grosso
February 7, 2023
FDA_Approved
New Drug Applications

FDA approves Elacestrant for ER-positive, HER2-negative, ESR1-Mutated Advanced or Metastatic Breast Cancer

On January 27, 2023, the U.S. Food and Drug Administration approved elacestrant for postmenopausal, non-pregnant women and adult men with advanced or metastatic ER-positive HER-2 negative breast cancer. Patients must have received

More
by Tiani Grosso
January 30, 2023
FDA_Approved
New Drug Applications

FDA Grants Accelerated Approval to Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

On January 27, 2023, the U.S. Food and Drug Administration approved Pirtobrutinib for adult patients with histologically confirmed relapsed or refractory Mantle cell lymphoma intolerant to two or more standard therapies, one

More
by Tiani Grosso
January 30, 2023
FDA_Approved
Lung Cancer/New Drug Applications

FDA Approves Pembrolizumab as Adjuvant therapy for Early-stage Resectable Non-small Cell Lung Cancer

On January 26, 2023, the U.S. Food and Drug Administration approved Pembrolizumab for patients with resectable, stage IB (≥4cm)-IIIA (as per the AJCC 7th Edition Staging System) non-small cell lung cancer after

More
by Tiani Grosso
January 27, 2023
FDA_Approved
New Drug Applications

FDA Approves Tucatinib Plus Trastuzumab for RAS Wild-type, HER2+ Metastatic Colorectal Cancer

On January 19, 2023, the U.S. Food and Drug Administration granted accelerated approval to Tucatinib plus Trastuzumab for adult patients with RAS wild-type metastatic colon cancer with HER2-positive status as detected at

More
by Tiani Grosso
January 26, 2023

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