Tiffany K. Ricks

Supplementary Table S1 from FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

William F. Maguire, Dow-Chung Chi, Sundeep Agrawal, Hee‐Koung Joeng et autres

Summary of molecular alterations in Cohort 1 of MAGNITUDE

Data from FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

William F. Maguire, Dow-Chung Chi, Sundeep Agrawal, Hee‐Koung Joeng et autres

Abstract On August 11, 2023, the FDA approved the fixed-dose combination of niraparib and abiraterone acetate (AA), with prednisone (AAP), for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer, as determined by an FDA-approved …

Supplementary Table S3 from FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

William F. Maguire, Dow-Chung Chi, Sundeep Agrawal, Hee‐Koung Joeng et autres

Summary of exposure and safety data for safety population (treated patients with BRCAm) of MAGNITUDE

Supplementary Table S2 from FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

William F. Maguire, Dow-Chung Chi, Sundeep Agrawal, Hee‐Koung Joeng et autres

Exploratory efficacy results by type of BRCA mutation in MAGNITUDE

FDA Approval Summary: Datopotamab Deruxtecan-dlnk for Treatment of Patients with Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer

Melanie Royce, Mirat Shah, Joyce Cheng, Mary Kate Bonner et autres

On January 17, 2025, the FDA approved datopotamab deruxtecan-dlnk (DATROWAY; Dato-DXd), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for the treatment of adults with unresectable or metastatic, hormone receptor-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable …

us (code pays fourni par la source)

US Food and Drug Administration Approval Summary: Inavolisib With Palbociclib and Fulvestrant for Endocrine-Resistant, PIK3CA -Mutated, Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative, Locally Advanced or Metastatic Breast Cancer

Suparna Wedam, Preeti Narayan, Haley Gittleman, Joyce Cheng et autres

PURPOSE The US Food and Drug Administration (FDA) approved inavolisib with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA -mutated, hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, locally advanced or metastatic breast cancer (MBC), as detected by an FDA-approved test, …

us (code pays fourni par la source)

FDA Approval Summary: Nogapendekin Alfa Inbakicept-pmln with BCG for BCG-Unresponsive Carcinoma In Situ

Brian L. Heiss, Elaine Chang, Hee‐Koung Joeng, Mallorie H. Fiero et autres

On April 22, 2024, the U.S. FDA granted regular approval to nogapendekin alfa inbakicept-pmln (N-803) with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors. Substantial evidence of …

us, jp (code pays fourni par la source)

US Food and Drug Administration Approval Summary: Ribociclib With an Aromatase Inhibitor in the Adjuvant Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Stage II and III High-Risk Early Breast Cancer Treatment Setting

Jennifer Gao, Tatiana M. Prowell, Haley Gittleman, Joyce Cheng et autres

PURPOSE On September 17, 2024, the US Food and Drug Administration (FDA) approved ribociclib in combination with an aromatase inhibitor (AI) for the adjuvant treatment of adults with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative stage II and III early …

us (code pays fourni par la source)

FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for BRCA -Mutated Metastatic Castration-Resistant Prostate Cancer

William F. Maguire, Dow-Chung Chi, Sundeep Agrawal, Hee‐Koung Joeng et autres

On August 11, 2023, the FDA approved the fixed-dose combination of niraparib and abiraterone acetate (AA), with prednisone (AAP), for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer, as determined by an FDA-approved test. …

us (code pays fourni par la source)

Overall Survival and the Evolving Benefit-Risk Assessment for Poly (ADP-ribose) Polymerase Inhibitors in Advanced Ovarian Cancer

Mirat Shah, Ting-Yu Chen, Gwynn Ison, Mallorie H. Fiero et autres

From 2014 through 2019, the US Food and Drug Administration (FDA) granted approval to six indications for poly (ADP-ribose) polymerase (PARP) inhibitors in advanced epithelial ovarian cancer (EOC). From 2022 through 2023, these six indications were withdrawn or narrowed after observation of …

us (code pays fourni par la source)

FDA Approval Summary: Capecitabine Labeling Update under Project Renewal

Sundeep Agrawal, C S Lee, William F. Pierce, Elizabeth Everhart et autres

On December 14, 2022, the FDA approved revisions to the United States Prescribing Information (USPI) for capecitabine that revised existing indications and dosage regimens, added new indications and their recommended dosage regimens, revised safety information, updated the description of the risk of …

us (code pays fourni par la source)

US Food and Drug Administration Approval Summary: Capivasertib With Fulvestrant for Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Locally Advanced or Metastatic Breast Cancer With PIK3CA / AKT1 / PTEN Alterations

Asma Dilawari, James Buturla, Christy Osgood, Xin Gao et autres

PURPOSE The US Food and Drug Administration (FDA) approved capivasertib in combination with fulvestrant for adult patients with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, locally advanced, or metastatic breast cancer (MBC) who have received at least one previous endocrine …

us (code pays fourni par la source)