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Table 2 FDA-approved therapeutic drugs for breast cancers

From: Small-molecule inhibitors, immune checkpoint inhibitors, and more: FDA-approved novel therapeutic drugs for solid tumors from 1991 to 2021

Drug (brand name)

Sponsor

Properties

Indication

Approval date

Review

Docetaxel (Taxotere)

Sanofi

Microtubule-stabilizing agent

Locally advanced or metastatic breast cancer

05/14/1996

P

Ixabepilone (Ixempra)

R-Pharm US

Microtubule-stabilizing agent

Locally advanced or metastatic breast cancer

10/16/2007

P

Eribulin mesylate (Halaven)

Eisai

Microtubule-destabilizing agent

Locally advanced or metastatic breast cancer

11/15/2010

P

Capecitabine (Xeloda)

Roche

A prodrug of 5-FU

Metastatic breast cancer

04/30/1998

P

Epirubicin HCl (Ellence)

Pfizer

DNA topoisomerase II inhibitor

Primary breast cancer with axillary node tumor involvement

09/15/1999

P, O

Anastrozole (Arimidex)

Ani pharms

Aromatase inhibitor

Advanced breast cancer in postmenopausal women

12/27/1995

S

Letrozole (Femara)

Novartis

Aromatase inhibitor

Advanced breast cancer

07/25/1997

S

Exemestane (Aromasin)

Pfizer

Aromatase inhibitor

ER-positive early breast cancer

10/21/1999

S, O

Toremifene citrate (Fareston)

Kyowa Kirin

ER inhibitor

ER-positive metastatic breast cancer

05/29/1997

S, O

Fulvestrant (Faslodex)

AstraZeneca

ER antagonist

HR-positive metastatic breast cancer

04/25/2002

S

Palbociclib (Ibrance)

Pfizer

CDK4/6 inhibitor

HER2-negative and HR-positive advanced or metastatic breast cancer

02/03/2015

P

Ribociclib succinate (Kisqali)

Novartis

CDK4/6 inhibitor

HR-positive, HER2-negative breast cancer

03/13/2017

P

Abemaciclib (Verzenio)

Eli Lilly

CDK4/6 inhibitor

HR-positive, HER2-negative breast cancer

09/28/2017

P

Trastuzumab (Herceptin)

Genentech

HER2-directed mAb

HER2-positive breast cancer

09/25/1998

P

Pertuzumab (Perjeta)

Genentech

HER2‑directed mAb

HER2‑positive metastatic breast cancer

06/08/2012

P

Margetuximab (Margenza)

MacroGenics

HER2-directed mAb

HER2-positive breast cancer

12/16/2020

S

Ado-trastuzumab emtansine (Kadcyla)

Genentech

HER2‑directed ADC

HER2‑positive metastatic breast cancer

02/22/2013

P

Trastuzumab deruxtecan (Enhertu)

Daiichi Sankyo

HER2-directed ADC

HER2-positive breast cancer

12/20/2019

P

Lapatinib ditosylate (Tykerb)

Novartis

HER2 and EGFR inhibitor

Advanced or metastatic breast cancer

03/13/2007

P

Neratinib maleate (Nerlynx)

Puma Biotech

EGFR, HER2, and HER4 inhibitor

HER2-overexpressed breast cancer

07/17/2017

S

Tucatinib (Tukysa)

Seagen

HER2 inhibitor

HER2-positive breast cancer

04/17/2020

P, O

Talazoparib tosylate (Talzenna)

Pfizer

PARP inhibitor

BRCA-mutated HER2-negative breast cancer

10/16/2018

P

Alpelisib (Piqray)

Novartis

PI3Kα inhibitor

PIK3CA-altered, HR-positive, and HER2-negative breast cancer

05/24/2019

P

Sacituzumab govitecan (Trodelvy)

Immunomedics

Trop-2-directed ADC

Triple-negative breast cancer (TNBC)

04/22/2020

P

  1. BRCA: Breast cancer susceptibility gene; CDK4/6 Cyclin-dependent kinases 4/6; ER Estrogen receptor; HER2/4 Human epidermal growth factor receptor 2/4; HR Hormone receptor; O Orphan; P Priority; PARP Poly (ADP-ribose) polymerase; PI3Kα Phosphatidylinositol 3-kinase α; S Standard; TKI Tyrosine kinase inhibitor