accelerated-approval
11 stories tagged "accelerated-approval"
Roche's KRAS Pill Beat the Older Drugs on Survival, an Endpoint Lumakras Never Won Against Chemotherapy
Median survival ran 17.7 months on divarasib and 12.0 on a control arm that was nine-tenths Lumakras, a drug whose own confirmatory trial showed no survival edge over chemotherapy.
CancerThe Number Behind GSK's Rectal Cancer Approval Is 47 Percent, Not 76
Independent reviewers confirmed a year-long complete response in 54 of 116 AZUR-1 patients. GSK's release also carried an exploratory 76 percent. For a narrow slice of rectal cancer patients, the drug may still spare them radiation and surgery.
Drugs & FDAThe FDA Fast-Tracked GSK's Rectal Cancer Drug and Left the Trial's Own Scorecard Out of Its Announcement
Independent reviewers found 47 percent of evaluable AZUR-1 patients held a complete response for a year, the trial's registered endpoint. The FDA's announcement quoted friendlier measures instead.
Drugs & FDAThe FDA Approved a Breast Cancer Drug Its Own Advisers Had Just Rejected, 6 to 3
An FDA advisory panel voted 6 to 3 that AstraZeneca had not shown its breast cancer drug delivered a meaningful benefit. The agency approved it four months later anyway.
Drugs & FDAThe FDA Approved a Breast Cancer Drug Four Months After Its Advisers Voted No
On April 30 the FDA's oncology advisers voted 6 to 3 that AstraZeneca's camizestrant hadn't shown a clinically meaningful benefit. On September 4 the agency approved it anyway, conceding in its own approval that the benefit is "not yet confirmed."
Drugs & FDAA $2.7 Million Gene Therapy, Approved Because Patients Needed Less Cornstarch
Ultragenyx's Genglycos won accelerated approval on a surrogate: a 31 percent cut in daily cornstarch. But the disease is low blood sugar, and by the company's own numbers the treated group spent slightly more time below 70 mg/dL, while liver enzymes spiked in 71 percent and every patient needed ster
Drugs & FDAThe FDA's Reviewers Called This Melanoma Data 'Not Interpretable.' Nine Days Later, the Agency Approved the Drug.
Twice the FDA rejected Replimune's engineered-herpes melanoma therapy, its reviewers calling the single-arm trial not interpretable. The design never changed. A 10-3 advisory vote came anyway, and nine days after that memo, the accelerated approval.
Drugs & FDAThe FDA Approved Moderna's mRNA Flu Shot for Seniors Without Proving It Works in Them
In February the FDA's own vaccine chief refused to even review it. One week later the agency reversed course, and the trial data never changed.
Drugs & FDAThe FDA Twice Called This Melanoma Trial Uninterpretable. Then It Approved the Drug, at $450,000 a Course.
Federal reviewers rejected Replimune's melanoma therapy twice, faulting a single-arm trial they called not adequate and well-controlled and its results uninterpretable. No new controlled data ever answered them. After a 10-3 advisory vote, the FDA approved it anyway, at $450,000 a course.
Drugs & FDAFDA's New Gene Therapy Shortcut Leans on 'Platform Knowledge.' Six Months Ago, They Revoked Sarepta's After Three Patient Deaths.
FDA's new gene therapy draft guidance invites sponsors to lean on "platform knowledge" to streamline submissions, six months after the agency revoked Sarepta's AAVrh74 platform designation following three patient deaths.
Drugs & FDAHepatitis Delta Has Waited Forty-Nine Years for a Drug. The FDA Made American Patients Wait Three Extra.
The FDA cleared bulevirtide for chronic hepatitis delta this week, six years after Europe started using it and three years after a U.S. application was turned down on manufacturing grounds. The wait is its own story.