Among several approved drugs by the Food and Drug Administration within the last two weeks is a combination HIV pill for some patients.
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) is a new once-a-day combination pill to treat HIV-1 infection in adults who never have been treated for HIV infection.
Stribild contains two previously approved HIV drugs plus two new drugs, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply. Cobicistat, a pharmacokinetic enhancer, is used to prolong the effect of elvitegravir and by inhibiting an enzyme that metabolizes certain HIV drugs. The combination of emtricitabine and tenofovir disoproxil fumarate, approved in 2004 and marketed as Truvada, blocks the action of another enzyme that HIV needs to replicate in a person’s body. Together, these drugs provide a complete treatment regimen for HIV infection, according to the FDA.
"Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to a single-pill regimen," Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a news release. "New combination HIV drugs like Stribild help simplify treatment regimens."
Late-stage prostate cancer
The FDA approved Xtandi (enzalutamide) to treat men with metastatic castration-resistant prostate cancer that has spread or recurred even with medical or surgical therapy to minimize testosterone.
Approved for prostate cancer patients previously treated with docetaxel, another anti-cancer treatment, Xtandi was reviewed under the FDA’s priority review program. The program provides for an expedited six-month review for drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists. Xtandi received FDA approval three months ahead of the initial target date.
Pediatric brain tumors
The FDA approved Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of the anti-cancer drug Afinitor (everolimus) used to treat a rare brain tumor called subependymal giant cell astrocytoma.
Afinitor Disperz is the first approved pediatric-specific dosage form developed for the treatment of a pediatric tumor, according to the FDA. It is recommended to treat patients ages 1 and older with tuberous sclerosis complex who are diagnosed with SEGA that cannot be treated with surgery. Before approval of this new dosage form, Afinitor was recommended for use only in patients ages 3 and older.
Afinitor Disperz is available in smaller dose increments than Afinitor, the adult dosage form. Afinitor Disperz also dissolves easily in a small volume of water, making it easy to administer to patients who are unable to swallow whole tablets to take their medication.
Neutropenia in cancer patients
The FDA approved Sicor Biotech’s tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia.
Tbo-filgrastim is intended for use in adults who have non-myeloid malignancies and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone marrow. This reduction in neutrophils may lead to febrile neutropenia.
Tbo-filgrastim stimulates the bone marrow to increase the production of neutrophils. It is administered as an injection beginning 24 hours after chemotherapy treatment.
Chronic myelogenous leukemia
The FDA approved Bosulif (bosutinib) to treat CML, a blood and bone marrow disease that usually affects older adults.
An estimated 5,430 men and women will be diagnosed with CML in 2012. Most people with CML have a genetic mutation, the Philadelphia chromosome, which causes the bone marrow to make an enzyme called tyrosine kinase. This enzyme triggers the development of too many abnormal and unhealthy white blood cells called granulocytes.
Bosulif is intended for patients with chronic, accelerated or blast phase Philadelphia chromosome-positive CML who are resistant to or who cannot tolerate other therapies, including imatinib. Bosulif works by blocking the signal of the tyrosine kinase that promotes the development of abnormal and unhealthy granulocytes.
Irritable bowel syndrome
The FDA approved Linzess (linaclotide) to treat chronic idiopathic constipation and irritable bowel syndrome with constipation in adults.
Linzess is a capsule taken once daily on an empty stomach at least 30 minutes before the first meal of the day. It can relieve constipation by helping bowel movements occur more often. In IBS-C, it also may help ease abdominal pain.
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) is a new once-a-day combination pill to treat HIV-1 infection in adults who never have been treated for HIV infection.
Stribild contains two previously approved HIV drugs plus two new drugs, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply. Cobicistat, a pharmacokinetic enhancer, is used to prolong the effect of elvitegravir and by inhibiting an enzyme that metabolizes certain HIV drugs. The combination of emtricitabine and tenofovir disoproxil fumarate, approved in 2004 and marketed as Truvada, blocks the action of another enzyme that HIV needs to replicate in a person’s body. Together, these drugs provide a complete treatment regimen for HIV infection, according to the FDA.
"Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to a single-pill regimen," Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a news release. "New combination HIV drugs like Stribild help simplify treatment regimens."
Late-stage prostate cancer
The FDA approved Xtandi (enzalutamide) to treat men with metastatic castration-resistant prostate cancer that has spread or recurred even with medical or surgical therapy to minimize testosterone.
Approved for prostate cancer patients previously treated with docetaxel, another anti-cancer treatment, Xtandi was reviewed under the FDA’s priority review program. The program provides for an expedited six-month review for drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists. Xtandi received FDA approval three months ahead of the initial target date.
Pediatric brain tumors
The FDA approved Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of the anti-cancer drug Afinitor (everolimus) used to treat a rare brain tumor called subependymal giant cell astrocytoma.
Afinitor Disperz is the first approved pediatric-specific dosage form developed for the treatment of a pediatric tumor, according to the FDA. It is recommended to treat patients ages 1 and older with tuberous sclerosis complex who are diagnosed with SEGA that cannot be treated with surgery. Before approval of this new dosage form, Afinitor was recommended for use only in patients ages 3 and older.
Afinitor Disperz is available in smaller dose increments than Afinitor, the adult dosage form. Afinitor Disperz also dissolves easily in a small volume of water, making it easy to administer to patients who are unable to swallow whole tablets to take their medication.
Neutropenia in cancer patients
The FDA approved Sicor Biotech’s tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia.
Tbo-filgrastim is intended for use in adults who have non-myeloid malignancies and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone marrow. This reduction in neutrophils may lead to febrile neutropenia.
Tbo-filgrastim stimulates the bone marrow to increase the production of neutrophils. It is administered as an injection beginning 24 hours after chemotherapy treatment.
Chronic myelogenous leukemia
The FDA approved Bosulif (bosutinib) to treat CML, a blood and bone marrow disease that usually affects older adults.
An estimated 5,430 men and women will be diagnosed with CML in 2012. Most people with CML have a genetic mutation, the Philadelphia chromosome, which causes the bone marrow to make an enzyme called tyrosine kinase. This enzyme triggers the development of too many abnormal and unhealthy white blood cells called granulocytes.
Bosulif is intended for patients with chronic, accelerated or blast phase Philadelphia chromosome-positive CML who are resistant to or who cannot tolerate other therapies, including imatinib. Bosulif works by blocking the signal of the tyrosine kinase that promotes the development of abnormal and unhealthy granulocytes.
Irritable bowel syndrome
The FDA approved Linzess (linaclotide) to treat chronic idiopathic constipation and irritable bowel syndrome with constipation in adults.
Linzess is a capsule taken once daily on an empty stomach at least 30 minutes before the first meal of the day. It can relieve constipation by helping bowel movements occur more often. In IBS-C, it also may help ease abdominal pain.
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