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A pair of PD-1 immunotherapies used in advanced hepatocellular carcinoma (HCC) met sharply different receptions from FDA advisers reviewing accelerated approvals that failed to show benefit in confirmatory trials.
In considering the two agents for previously treated HCC, the Oncologic Drugs Advisory Committee (ODAC) on Thursday unanimously recommended that FDA maintain its accelerated approval of pembrolizumab (Keytruda), by a vote of 8-0, but split over nivolumab (Opdivo), with a 5-4 vote in favor of revoking the indication.
The divided decision largely stemmed from whether ongoing trials would offer new evidence to support the indications. ODAC members took a wait-and-see approach with pembrolizumab given the imminent readout of KEYNOTE-394, a placebo-controlled second-line trial being conducted in Asia. But with nivolumab, they remained unconvinced that any ongoing trial from drugmaker Bristol Myers Squibb (BMS) would adequately provide insight for the c
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An advisory committee recommended that the FDA revoke the accelerated approval for pembrolizumab (Keytruda) as a third-line option in gastric or gastroesophageal junction (GEJ) cancer.
With a vote of 6-2, the Oncologic Drugs Advisory Committee (ODAC) on Thursday recommended against maintaining the PD-1 immune checkpoint inhibitor s indication for patients with metastatic or recurrent locally advanced gastric or GEJ cancers with tumors expressing PD-L1.
Committee members overwhelmingly cited the new availability of a PD-1 inhibitor, in combination with chemotherapy, in the upfront setting, as well as the fact that patients who have already received chemotherapy alone as their initial therapy could still access pembrolizumab through expanded use programs.
Women warned dead fish smell could mean they have vagina infection
Women have been told not to worry if their vagina isn t fragrant as there is a lot of things than can affect its odour. However experts say that they should watch out for a fishy smell
15:59, 27 APR 2021
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Scientists launch study to find out if COVID-19 vaccines are causing period changes after hundreds of women notice irregularities
Dr Kathryn Clancy and Dr Katherine Lee said they both experienced abnormal periods after getting the COVID-19 vaccine
When they described their experiences on Twitter, hundreds of women replied that their menstrual cycles were also abnormal following the shot
Clancy and Lee have now launched a study, including a survey in which women can document their menstrual experiences after vaccination
As of Monday, more than 25,000 women have completed the questionnaire
Experts say there is currently no documented link between the COVID-19 vaccine and periods, and no danger in getting the jab