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Ovarian Cancer Canada is developing a patient submission to Canada's Drug Agency and INESSS (Institut national d'excellence en santé et services sociaux) to help inform their decision on ELAHERE, a drug for platinum-resistant ovarian cancer patients that is not currently available in Canada.  

If you (patients) or your loved one (caregivers) has platinum-resistant ovarian cancer, we want to hear from you. Share your experience by completing our online survey by February 25. Your insights are essential to shaping decisions that impact access to treatment in Canada. 

Patients:https://www.surveymonkey.com/r/Patient_EN

Caregivers: https://www.surveymonkey.com/r/caregiverEN

#TreatmentandsideeffectsPost
#OCCinfoandupdates

@mfallis_OCC What a timely invite. I am definitely going to participate! I was just going to post the following:

Mirvetuximab Soranvanstine-gynx (Elahere)

My Onc mentioned that, finally, Elahere is being reviewed by Health Canada. I cannot find when it was submitted and when I asked my Onc if there was any chance it would fast tracked (like it was for FDA)…she nearly fell off her chair with laughter. So I guess we just be glad that it is under review and let the process run its course. I have read that it could take 6 months to 1 year (rarely up to 2 years).

From what I've read, it is for advanced platinum-resistant OC and for those with a high FRa expression (determined from archived tissue sample or fresh biopsy).

Here is the NCI blurb on the drug https://www.cancer.gov/about-cancer/treatment/drugs/mirvetuximab-soravtansine-gynx

The part in this that gives me pause is "…one to three types of systemic therapy." On further reading, it is being offered (in the States) to patients who have received 1-3 systemic treatment regimens. Link to Elahere site https://www.elahere.com/about-elahere

Egad…I'm pretty sure I'll not be eligible on that criteria alone! The good news is, once it is approved, there are a lot of ladies out there who will meet the criteria and benefit from this drug. 

🤔 Wow! It takes between 8 to 15 years from development to drug approval.

#Treatmentandsideeffects

That is great to hear that it's being reviewed! I reached out to the Health Minister a couple of times in January with questions about Elahere's availability in Canada. My mom tried to access this drug in the U.S. but was unfortunately unsuccessful and the financial affordability was not an option.  Both my aunt and mom did extensive research on Elahere, and from what they found, it has a 40% efficacy rate for platinum-resistant ovarian cancer. However, it also comes with more severe side effects, particularly affecting vision.

It ultimately lies with the drug manufacturer from what I understand.  This is part of a reply that I received back.  

"Directorate of Health Canada for response.  Health Canada is the federal regulator responsible for the review and authorization oftherapeutic products for use in Canada. For any drugs to be made available in Canada, the manufacturer would need to make a submission of all the evidence needed to support safety, efficacy and manufacturing quality. At this time, Health Canada has not received any submission from the manufacturer of Elahere. For your information, when a product is filed for evaluation with Health Canada, they are listed under Drug and Health Product Submissions Under Review (SUR) web page found here. When a submission is filed with us for approval, Health Canada has 300 days to complete a thorough assessment of the submission. In certain cases, a shorter review (180 day; priority review) can be done if a product offers significant benefits over existing therapies or when no approved therapies are available. You may wish to contact the manufacturer to enquire about their plans to seek approval in Canada for Elahere.

@mymomisawarrior

Hi. Thanks for sticking with us! Your continued support and encouragement are very much appreciated.

Yes…I remember when your Mom was doing all the leg work on this front. Thanks for sharing the Health Canada response.

I hope you are doing well.

Hi again.

So...I just tried to enter the survey...and I was stopped after the first question because I do not meet the 1-3 lines of treatment criteria. So...I wrote to the contact person.

They do not want to hear from all PROC patients...only those that meet the criteria. They have already excluded a large group of PROC patients and do not want our "insights" to "shape decisions that impact access to treatment in Canada." So frustrating.

Hi all.

I received a response from OCC regarding my frustration at not being able to complete the survey. The survey was terminated after question 1 about the number of lines of treatment - I did not meet the criteria! 

Good news…for those of you who are not able to complete the survey online but still want to provide feedback/insights, OCC is conducting telephone interviews over the next two weeks.

If you are interested, contact

Alexandria Tadman 

atadman@ovariancanada.org

I appreciate OCC's commitment to gathering feedback and engaging with as many PROC Teal Sisters as possible. 

I just heard that the drug company has made there submission to Health Canada for Elahere!!

Here is the email I received…

Thanks @GloHo for the information. Progress!!!!!