Approval was based on a study of 80 patients with relapsed or refractory DLBCL randomly assigned to receive either Polivy with bendamustine and rituximab or bendamustine and rituximab alone.

Researchers found a complete response rate of 40 percent with Polivy plus bendamustine and rituximab compared with 18 percent with bendamustine and rituximab alone. Twenty-five patients achieved a partial or complete response with Polivy plus bendamustine and rituximab; 64 percent of these patients had a duration of response of six months or longer and 48 percent achieved a duration of response of at least one year.
The most commonly reported side effects of the combination of Polivy plus bendamustine and rituximab included neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, fever, decreased appetite, and pneumonia.
Patients should be closely monitored for infusion-related reactions, low blood counts, fatal or serious infections, tumor lysis syndrome, hepatotoxicity, and progressive multifocal leukoencephalopathy. The FDA noted that women of reproductive age should be advised to use effective contraception during treatment and for three months following the last dose, and those who are pregnant or breastfeeding should not be treated with Polivy.
Approval of Polivy was granted to Genentech.

A healthy diet may trigger a better response to a certain kind of melanoma treatment. How?

New research suggests that a diet that's full of fiber appears to lead to more diverse intestinal bacteria (microbiome). In turn, a thriving gut microbiome is linked to a stronger response to an immune therapy for the aggressive skin cancer. "We found that patients eating a high-fiber diet at the start of therapy were about five times more likely to respond to the anti-PD-1 immunotherapy," said study author Christine Spencer. She's a research scientist with the Parker Institute for Cancer Immunotherapy in San Francisco. Anti-PD-1 immunotherapy helps the immune system recognize cancer cells as dangerous cells that need to be destroyed, according to the American Cancer Society (ACS). The cancer drugs Keytruda and Opdivo are examples of this type of immunotherapy. Melanoma is a type of skin cancer. It only accounts for about 1 percent of all skin cancers, but is responsible for most skin cancer deaths, the ACS says. Several recent studies have suggested that a ...

Далее...

Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose

Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch, Twirla PRINCETON, N.J., May 17, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced it has resubmitted to the U.S. Food and Drug Administration (FDA) the NDA for its lead product candidate, Twirla®, an investigational low-dose combined hormonal contraceptive patch (AG200-15). Agile resubmitted the NDA in response to a December 2017 Complete Response Letter (CRL) from the FDA, which identified deficiencies relating to (i) quality control adhesion test methods for the Twirla manufacturing process, (ii) observations identified during an inspection of a facility of our third-party manufacturer for the Twirla NDA that must be resolved, and (iii) questions on the in vivo adhesion properties of Twirla and their potential relationship to the SECURE clinical trial results. The resubmitted NDA includes the results from a...

Далее...

Diet and nutrition

The study included more than 1,000 overweight or obese people in the United Kingdom, the Netherlands, Germany and Spain who were at risk for depression, but were not currently depressed. Excess weight is often linked with depression, the researchers noted. Half of the study participants took daily supplements containing folic acid, vitamin D, omega-3 fish oils, zinc and selenium. Half took a placebo pill. Half were also counseled about their eating habits and urged to limit snacking and follow a healthy Mediterranean-style diet. In a one-year follow-up, the researchers discovered that the supplements worked no better than the placebo in helping ward off depression. Similarly, the counseling was not effective overall, though it seemed to help prevent depression in participants who attended a recommended number of sessions. That suggests counseling works only if people get an adequate "dose" of therapy and make significant changes in their diet, according to the study pu...

Далее...

MD Watch Tower

Поиск по этому блогу