Ibrance: FDA has expanded approved use of metastatic breast cancer treatment to include male patients
The FDA ( U.S. Food and Drug Administration ) has extended the indication of Ibrance ( Palbociclib ) capsules in combination with specific endocrine therapies for hormone receptor-positive ( HR+ ), human epidermal growth factor receptor 2-negative ( HER2- ) advanced or metastatic breast cancer in male patients.
Breast cancer is rare in males with only 2,670 cases of male breast cancer estimated in 2019, less than 1% of all cases of breast cancer.
The majority of breast tumors in male patients express hormone receptors.
Men are more likely to be diagnosed at an older age, with a more advanced stage of disease. Metastatic breast cancer is breast cancer that has spread beyond the breast to other organs in the body ( most often the bones, lungs, liver or brain ).
When breast cancer is hormone-receptor positive, patients may be treated with hormone therapy ( endocrine therapy ) or chemotherapy.
Endocrine therapy slows or stops the growth of hormone-sensitive tumors by blocking the body’s ability to produce hormones or by interfering with effects of hormones on breast cancer cells. There are several FDA-approved endocrine based therapies available for HR-positive metastatic breast cancer patients. Certain treatments are gender-neutral in their indication, but some therapies have been approved only for women, although they are often prescribed for male patients. According to the current clinical practice standards, male patients with breast cancer are treated similarly to women with breast cancer.
Ibrance was initially approved in 2015. It is a kinase inhibitor, approved in combination with an aromatase inhibitor as the first hormonal-based therapy in women who have gone through menopause and in men, or with Fulvestrant in patients whose disease progressed following hormonal therapy.
Pfizer provided the results of an analysis of real-world data ( RWD ) from electronic health records ( EHRs ) as additional supportive data to characterize the use of Palbociclib in combination with endocrine therapy ( aromatase inhibitor or Fulvestrant ) in male patients with breast cancer based on observed tumor responses in this rare subset of patients with breast cancer.
The most common side effects of patients taking Ibrance are infections, leukopenia ( low levels of white blood cells ), fatigue, nausea, stomatitis ( inflammation of the mouth and lips ), anemia ( low levels of red blood cells ), hair loss, diarrhea and thrombocytopenia ( low levels of thrombocytes, also known as platelets, in the blood ).
Other common side effects reported are rash, vomiting, decreased appetite, asthenia ( abnormal physical weakness or lack of energy ) and fever.
Health care providers are advised to monitor a patient’s blood count for neutropenia ( low levels of white blood cells called neutrophils ).
Patients should have their blood count checked prior to starting Ibrance and at the beginning of each cycle, as well as on day 15 of the first two cycles and as clinically indicated.
Because of the potential for genotoxicity, health care providers are advised to tell male patients with female partners of reproductive potential to use effective contraception during treatment with Ibrance and for three months after the last dose.
Women who are pregnant or breastfeeding should not take Ibrance because it may cause harm to a developing fetus or newborn baby. ( Xagena )
Source: FDA, 2019
FDA has approved Ayvakit, the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors
The FDA ( U.S. Food and Drug Administration ) has approved Ayvakit ( Avapritinib ) for the treatment of adults...
Acid reflux drugs that are sometimes recommended to ease stomach problems during cancer treatment may have an unintended side effect:...
SARS-CoV-2 uses the angiotensin-converting enzyme ( ACE ) 2 receptor for entry into target cells. ACE2 is predominantly expressed by...
Dapagliflozin has reduced the incidence of heart failure worsening or cardiovascular death in a sub-analysis from landmark phase III DAPA-HF trial
New data from a sub-analysis of the landmark phase III DAPA-HF ( Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure...
Renal and cardiovascular effects of SGLT2 inhibitors in patients with type 2 diabetes mellitus and chronic kidney disease
Chronic kidney disease ( CKD ) risk is elevated in patients with type 2 diabetes mellitus ( T2DM ). Disease...
FDA has approved Qinlock, first drug for fourth-line treatment of advanced gastrointestinal stromal tumors
The FDA ( U.S. Food and Drug Administration ) has approved Qinlock ( Ripretinib ) tablets as the first new...
Tabrecta for the treatment of adult patients with MET-positive non-small cell lung cancer: FDA approved
The FDA ( U.S. Food and Drug Administration ) has approved Tabrecta ( Capmatinib ) for the treatment of adult...
SGLT2 inhibitors, compared with DPP-4 inhibitors, associated with reduced risk of serious renal events
The objective of a cohort study was to assess the association between use of sodium-glucose co-transporter 2 ( SGLT2 )...
Primary analysis of CITYSCAPE study of the anti-TIGIT antibody Tiragolumab plus Atezolizumab versus Atezolizumab as first-line treatment in patients with PD-L1-selected NSCLC
The immunomodulatory receptor TIGIT is a novel inhibitory immune checkpoint present on activated T cells and NK cells in multiple...
Rinvoq, an oral JAK inhibitor for the treatment of moderate to severe rheumatoid arthritis, approved by FDA
The FDA ( U.S. Food and Drug Administration ) has approved Rinvoq ( Upadacitinib ), a 15 mg, once-daily oral...