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Oncology Accelerated Approval Withdrawals: Which Indications Need Confirmation Next?

 
• By Tara Hansen

US FDA’s ‘industry-wide evaluation’ of accelerated approvals has already led to withdrawals of four PD-1/PD-L1 inhibitor indications, with the Oncologic Drugs Advisory Committee set to review another six next week. Over the next two years, an additional five indications may be up for review.

Car gas and brake pedals

Since the US Food and Drug Administration introduced the accelerated approval program in 1992, the agency has granted more than 250 approvals under this expedited pathway. The program has brought a number of important therapies to market earlier than would have been expected under the regular review process, including cancer immunotherapies.

However, despite the high-profile failure of several confirmatory trials for Genentech, Inc. ’s PD-L1 inhibitor Tecentriq (atezolizumab), Merck...

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Faster HTA Reviews & Pricing Reform Could Help Fix Canada’s Drug Access Woes

 
• By Eliza Slawther

Canadian politicians must “move quickly” to introduce policies that will speed up access to medicines, such as by broadening criteria for the temporary reimbursement of medicines, the Canadian Chamber of Commerce says.

New EU Filings

 
• By Neena Brizmohun

Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Expedited Reviews For China-Originated Drugs Shift Back Home

 
• By Xu Hu

The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients After FDA Reverses Course

 
• By Mandy Jackson

The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.

More from Pathways & Standards

Mexico Speeds Up Market Access With Regulatory Reliance Guidelines

 
• By Francesca Bruce

Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.

UK Approves Biogen’s Qalsody After England Revises Reimbursement Approach

 
• By Eliza Slawther

Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.

Danish Medicines Agency Wants Companies To Use “Better Data Format” To Submit Bioequivalence Studies

 
• By Anabel Costa-Ferreira

The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.