U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review

Arora, Shaily; Narayan, Preeti; Osgood, Christy; Wedam, Suparna; Prowell, Tatiana M.; Gao, Jennifer; Shah, Mirat; Krol, Danielle; Wahby, Sakar; Royce, Melanie; Ghosh, Soma; Philip, Reena; Ison, Gwynn; Berman, Tara; Brus, Christina; Bloomquist, Erik; Fiero, Mallorie H.; Tang, Shenghui; Pazdur, Richard; Ibrahim, Amna; Amiri‐Kordestani, Laleh; Beaver, Julia A.

doi:10.1158/1078-0432.ccr-21-2600

Cited by 41 publications

(29 citation statements)

References 52 publications

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“…AFFILIATIONS 1 Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 2 Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD…”

Section: Data Sharing Statementmentioning

confidence: 99%

FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer

Royce

Osgood

Mulkey

et al. 2022

JCO

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PURPOSE The US Food and Drug Administration approved abemaciclib in combination with endocrine therapy (ET) for the adjuvant treatment of adult patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative, node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score ≥ 20%. PATIENTS AND METHODS The approval was based on monarchE, a phase III, open-label, 2-cohort, multicenter trial of patients with EBC randomly assigned to receive abemaciclib plus ET (n = 2,808) or ET alone (n = 2,829). Abemaciclib was given at 150 mg orally twice daily for 2 years. RESULTS Invasive disease-free survival (IDFS) in the intent-to-treat population was statistically significant at the second IDFS interim analysis (IA; March 2020; hazard ratio [HR; 95% CI], 0.747 [0.598 to 0.932]; P = .0096); however, only 12.5% of patients had completed adjuvant therapy, and the HR for overall survival (OS) was > 1. A prespecified, controlled analysis of IDFS in patients with Ki-67 ≥ 20% in cohort 1 was statistically significant at the final IDFS analysis (July 2020; HR [95% CI], 0.643 [0.475 to 0.872]; P = .0042). At the first OS IA (April 2021), the majority of patients had completed adjuvant therapy, IDFS remained consistent, and potential detriment in OS was not observed for this subgroup (HR [95% CI], 0.767 [0.511 to 1.152]). The HR for OS in the intent-to-treat population at OS IA remained > 1 (HR [95% CI], 1.091 [0.818 to 1.455]). More patients in the abemaciclib plus ET arm experienced treatment emergent adverse events (all grades 98.4% v 88.8%, grade 3 ≥ 49.7% v 16.3%). CONCLUSION The approval of abemaciclib in adjuvant EBC was limited to patients with high risk of recurrence and Ki-67 ≥ 20%, given their favorable benefit:risk with a statistically significant IDFS advantage and no observed detriment on survival.

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Section: Data Sharing Statementmentioning

confidence: 99%

FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer

Royce

Osgood

Mulkey

et al. 2022

JCO

Self Cite

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“…Further, side effects might include osteoporosis, cardiovascular problems, and induced drug resistance. Accordingly, there is an urgent demand for continuous progress in the discovery and development of novel, safe, and effective lead compounds for long-term cancer therapy with less side effects [ 6 , 7 , 8 , 9 ].…”

Section: Introductionmentioning

confidence: 99%

Novel 1,3-Thiazole Analogues with Potent Activity against Breast Cancer: A Design, Synthesis, In Vitro, and In Silico Study

et al. 2022

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Breast cancer is the most common cancer in women, responsible for over half a million deaths in 2020. Almost 75% of FDA-approved drugs are mainly nitrogen- and sulfur-containing heterocyclic compounds, implying the importance of such compounds in drug discovery. Among heterocycles, thiazole-based heterocyclic compounds have demonstrated a broad range of pharmacological activities. In the present study, a novel set of 1,3-thiazole derivatives was designed and synthesized based on the coupling of acetophenone derivatives, and phenacyl bromide was substituted as a key reaction step. The activity of synthesized compounds was screened against the proliferation of two breast cancer cell lines (MCF-7 and MDA-MB-231). Almost all compounds exhibited a considerable antiproliferative activity toward the breast cancer cells as compared to staurosporine, with no significant cytotoxicity toward the epithelial cells. Among the synthesized compounds, compound 4 exhibited the most potent antiproliferative activity, with an IC50 of 5.73 and 12.15 µM toward MCF-7 and MDA-MB-231 cells, respectively, compared to staurosporine (IC50 = 6.77 and 7.03 µM, respectively). Exploring the mechanistic insights responsible for the antiproliferative activity of compound 4 revealed that compound 4 possesses a significant inhibitory activity toward the vascular endothelial growth factor receptor-2 (VEGFR-2) with (IC50 = 0.093 µM) compared to Sorafenib (IC50 = 0.059 µM). Further, compound 4 showed the ability to induce programmed cell death by triggering apoptosis and necrosis in MCF-7 cells and to induce cell cycle arrest on MCF-7 cells at the G1 stage while decreasing the cellular population in the G2/M phase. Finally, detailed in silico molecular docking studies affirmed that this class of compounds possesses a considerable binding affinity toward VEGFR2 proteins. Overall, these results indicate that compound 4 could be a promising lead compound for developing potent anti-breast cancer compounds.

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“…The FDA has approved 37 drugs for current usage. [27,28] Shaik Baji Baba received his Masters's degree in Pharmaceutical Chemistry from Mahatma Gandhi University, Nalgonda, India, in 2019. Currently, he is pursuing a PhD in Pharmaceutical Chemistry at the College of Health Science, University of Kwazulu Natal, Durban, South Africa.…”

Section: Introductionmentioning

confidence: 99%

“…Almost 700 cancer‐related drugs are currently under different phases of clinical and preclinical testing, and nearly 100 drugs have been approved and are currently on the market. The FDA has approved 37 drugs for current usage [27,28] …”

Section: Introductionmentioning

confidence: 99%

Role of Natural Products in Developing Novel Anticancer Agents: A Perspective

Shaik

Katari

Jonnalagadda

2022

Chemistry & Biodiversity

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Cancer is a heterogeneous disease and is one of the significant health issues, especially in public health systems around the world. Natural products and their structural derivatives with outstanding chemical diversity have been investigated for potential anti‐cancer agents. Many natural products revealing potential anti‐cancer properties such as cytotoxicity, proliferation inhibition, induced apoptosis, retard metastasis, suppressing angiogenesis, and improved chemotherapy have been isolated from various plants and herbs. Several promising lead molecules have been identified recently; a few are in the clinical trial stage. This short communication summarises the role of natural products and their analogs in anti‐cancer drug developments, especially plant, marine and microbial‐based anti‐cancer agents.

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U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review

Cited by 41 publications

References 52 publications

FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer

FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer

Novel 1,3-Thiazole Analogues with Potent Activity against Breast Cancer: A Design, Synthesis, In Vitro, and In Silico Study

Role of Natural Products in Developing Novel Anticancer Agents: A Perspective

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