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Weekly Drug News Round-Up: August 23, 2017

Pfizer's Besponsa FDA-Approved for Advanced Forms of ALL

B-cell precursor ALL is a rapidly progressing bone marrow cancer that results in too many immature white blood cells Read More...

Life expectancy after a return of acute lymphoblastic leukemia is low and treatment options are few. The U.S. Food and Drug Administration has approved Pfizer's Besponsa (inotuzumab ozogamicin), a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. Besponsa binds to B-cell ALL cancer cells that express the CD22 antigen, blocking the growth of cancerous cells. In studies, 35.8% of those who received Besponsa experienced complete response (CR) for a median 8 months; of the patients who received alternative chemotherapy, 17.4 percent experienced CR for a median 4.9 months.

FDA Clears Duzallo for Hyperuricemia in Patients with Uncontrolled Gout

Duzallo addresses both overproduction and underexcretion of serum uric acid Read More...

Gout is a painful form of inflammatory arthritis. Duzallo is now approved as a combination, once-daily, oral xanthine oxidase inhibitor (allopurinol) and URAT1 inhibitor (lesinurad) for use in patients who have not achieved target serum uric acid (sUA) levels with allopurinol alone. In studies, Duzallo doubled the number of patients who achieved sUA of <6 mg/dL at month 6, reduced the mean sUA level to <6 mg/dL by month 1 and maintained that level through month 12. Common side effects include headache, influenza, elevated blood creatinine (a measure of kidney function), and heartburn.

Tablet Form of Lynparza Receives Added FDA Approval for Ovarian Cancer

Lynparza tablets are given as two tablets twice daily as opposed to eight capsules twice daily Read More…

Lynparza (olaparib) is a poly ADP ribose polymerase (PARP) inhibitor for the treatment of advanced ovarian cancer, first available in a capsule dosage form. The FDA has now approved a tablet formulation of AstraZeneca and Merck’s Lynparza that will lower the total number of pills taken each day. Lynparza tablets are now indicated as a maintenance treatment of adults with recurrent ovarian cancer regardless of BRCA-mutation status. Also, the new tablet form is now fully approved for BRCA-mutated ovarian cancer beyond the third-line setting (a conversion from the accelerated approval). Do not substitute the Lynparza tablets with the capsules on a milligram-to-milligram basis due to differences in bioavailability.

Steroid Pills Not Shown Effective Against Bronchitis Cough: Study

No patients in this study had asthma or bacterial infections Read More...

According to medical experts, oral corticosteroid medications are increasingly being used to treat the symptoms of chest infections in patients, but without sufficient evidence. A new study published in the Journal of the American Medical Association (JAMA) this week does not support this practice. In a randomized trial, 401 adults with an acute respiratory tract infection such as bronchitis were treated with oral prednisolone, 40 milligrams (mg) daily for 5 days, and compared to a group who received placebo. Results demonstrated that patients on corticosteroids had no reductions in severity or duration of their cough or other symptoms, compared to those who took the placebo.

New Study Further Supports Intensive Blood Pressure Control

Researchers used data tallied from more than 9,600 patients in the SPRINT trial Read More...

A new study in the New England Journal of Medicine addresses the question - again - of the benefits of intensive high blood pressure lowering below 120 mm Hg. The SPRINT trial was a U.S. government-funded trial that challenged the standard approach to blood pressure lowering (<140 mm Hg systolic) to more intensive lowering (<120 mm Hg systolic). That study found added cardiovascular benefits to intensive lowering, but it was controversial due to a possible risk of greater side effects with elevated drug doses. Now, using self-reported data on day-to-day well-being, the team found that patients on aggressive treatment fared just as well as those on standard care, even the elderly, frail patient.