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FDA Approves Abemaciclib to Treat Women With Certain Breast Cancers

FDA Approves Abemaciclib to Treat Women With Certain Breast Cancers

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  • Abemaciclib is approved by FDA for treating women with hormone receptor (HR) 2 positive, human epidermal growth factor receptor (HER) 2 negative advanced or metastatic breast cancer.
  • It can be treated as a monotherapy or combination therapy depending upon the type of breast cancer and the treatment history.
  • The new treatment with abemaciclib has been found to be an effective and safe mode of therapy that delays the need for chemotherapy infusion and the infusion-related side effects.

Breast cancer is the most common cause of cancer in women. It occurs due to uncontrollable growth of breast cells as a result of mutation or abnormality of genes responsible for regulating the growth of cells. Breast cancer can occur either in the milk-producing glands or in the ducts or passages that drain milk. If not treated initially the cancer cells can spread to the nearby healthy tissues or underarm lymph nodes. A mammogram is recommended for people who have a family history of breast cancer or ovarian cancer and for women who are 40 years and above.

FDA approves Abemaciclib for treating HR-positive or metastatic breast cancer

Abemaciclib approved for treating women with hormone receptor 2 positive and human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer. Abemaciclib can be given as a monotherapy in breast cancer treated with hormone therapy and chemotherapy. A combination of abemaciclib with fulvestrant can also be considered for women with breast cancer who have been already treated with endocrine therapy.


MONARCH 1 and MONARCH 2 were the trials carried out to study the safety and efficacy of abemaciclib. However, results of MONARCH 3 clinical trial led to the FDA approval as the trial showed an increase in the progression-free survival (PFS) for the period women lived longer without the progression of cancer. MONARCH 3 was a randomized, double-blinded, placebo-controlled, multicenter clinical trial which involved 493 patients.

In MONARCH 3 clinical trial, patients were given abemaciclib 150 mg orally twice a day or placebo along with letrozole or anastrozole, an aromatase inhibitor. Patients who received abemaciclib showed an estimated median PFS of about 28.2 months, whereas
patients received placebo showed a PFS of 14.8 months. The recommended dose of abemaciclib is 150 mg prescribed with an aromatase inhibitor twice daily taken orally with or without food.

What are the common side effects of abemaciclib?

  • Nausea and vomiting
  • Fatigue
  • Anemia
  • Loss of hair
  • Decreased white blood cells
  • Low neutrophils count
  • Occurrence of infections
  • Diarrhea
  • Pain in the stomach
  • Decreased appetite

What are the symptoms of breast cancer?

  • Soreness of nipples
  • Formation of new lumps
  • Nipple discharge
  • Turning inward or retraction of nipples
  • Swollen breasts with red rashes
  • Pain in the nipples or breast
  • Lumps in the underarm area
  • Irritation of breast skin

What are the risk factors for breast cancer?

  • Old age
  • Mutation of genes of BRCA 1 and BRCA 2
  • Obesity
  • Dense breasts
  • Hormone replacement therapy
  • Taking birth control pills
  • Alcohol consumption
  • Having children at a later age
References :
  1. FDA Approves Abemaciclib for Certain HR+ Metastatic Breast Cancers - (http://www.lbbc.org/news-opinion/fda-approves-abemaciclib-certain-hr-metastatic-breast-cancers)
  2. FDA approves abemaciclib as initial therapy for HR-positive, HER2-negative metastatic breast cancer - (https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm598404.htm)
  3. Abemaciclib Approval Expands Initial Treatment Options for Advanced Breast Cancer - (https://www.cancer.gov/news-events/cancer-currents-blog/2018/abemaciclib-fda-breast-cancer-first-line)
  4. Breast Cancer - (https://www.cancer.org.au/about-cancer/types-of-cancer/breast-cancer/)
  5. About Breast Cancer - (https://medlineplus.gov/breastcancer.html)
Source: Medindia

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