Amgen drug reduces risk of prostate cancer spreading to bones, study finds
THOUSAND OAKS, Calif. — A drug made by Amgen delayed the spread of prostate cancer to the bones in men with the disease and prolonged the survival of men with the condition, according to results of a late-stage clinical trial.
Published in The Lancet, the phase-3 "147 study" evaluated Xgeva (denosumab) in men with nonmetastatic, castration-resistant prostate cancer, also known as CRPC. The study "significantly prolonged" survival without bone metastasis, delayed time to bone metastasis and reduced the risk of symptomatic bone metastasis. The company has filed a regulatory approval application with the Food and Drug Administration seeking approval for Xgeva to reduce the risk of CRPC spreading to the bones.
"The prevention of bone metastases is a major unmet medical need for men with castration-resistant prostate cancer," Massachusetts General Hospital Cancer Center medical professor Matthew Smith said. "The more than four-month increase in bone metastasis-free survival with Xgeva treatment is a clinically significant finding that has the potential to improve the management of men living with prostate cancer."
Aceto launches generic drugs for infections, malaria
PORT WASHINGTON, N.Y. — A subsidiary of Aceto Corp. has launched two generic drugs for treating infectious diseases, the company said Monday.
Aceto said its Rising Pharmaceuticals subsidiary launched flucytosine capsules, a version of Valeant Pharmaceuticals International’s Ancobon, used to treat serious infections; and chloroquine phosphate tablets, a generic version of Sanofi’s malaria drug Aralen. The drugs’ branded versions had sales of $20 million during the 12-month period ended in June, Aceto said.
"The chloroquine phosphate launch marks the first leveraging of a product by Rising that was brought to them directly as a result of Aceto’s worldwide sourcing capabilities," Aceto chairman and CEO Albert Eilender said. "This illustrates the synergistic business opportunities we believe will become more plentiful as we move forward."
NCPA expresses concerns over restricted-network plans
ALEXANDRIA, Va. — Many so-called restricted-network Medicare Part D prescription drug plans don’t give adequate pharmacy access to rural residents and are deceptively marketed to patients, the National Community Pharmacists Association said Monday.
The plans include those offered by a number of national retail chains and health insurers.
The NCPA said the plans were being marketed to patients and featured on Medicare’s Plan Finder without making clear that the lowest advertised drug prices were available only at a relatively few, selected pharmacies. Second, the group said, patients in rural areas may not have full access to them.
"From day one, these overly restrictive drug plans have raised questions about ensuring adequate access to pharmacy care, which is why NCPA has opposed them," NCPA CEO B. Douglas Hoey said. "We urge Medicare officials to consider these marketing and patient access concerns and take action in the interest of seniors."
The group recently sent a letter to the Centers for Medicare and Medicaid Services, asking it to change the Plan Finder tool to clarify that lower-cost prescription drug cost sharing is only available at the preferred pharmacy and require restricted-network plans to state in all communications that patients must go to the preferred pharmacy in order to obtain the lower drug costs.
"We encourage every Medicare beneficiary to talk to a community pharmacist about choosing the right Medicare drug plan," Hoey said. "Pharmacists can be a tremendous resource to Medicare patients by educating them about the enrollment process and helping them ‘plug in their drugs’ using Medicare’s Plan Finder tool at Medicare.gov."