Overview
In this section of the PI you will confirm that Carvykti can only be administer in centers that have completed this type of certification/program
What is REMs- Risk Evaluation and Mitigation Strategy Program
PI sections:
A single dose of Carvykti contains this cell suspension and would be located here in the PI
What is 0.75×10⁶ CAR-positive viable T cells per kg?
PI: Section 2 Dosing and Administration, Section 3 Dosage forms & Strengths, Section 6 Clinical Trials Experience, Section 14 Clinical Studies
21.8 months is the duration of response with this most recent update and is located in this section of the PI
What is 2 year update?
PI: Section 14 Clinical Studies
Neurotox or ICANS was seen in this % of patients on study and this information is found here in the PI
What is 21%
PI: Section 5 Warnings and Precautions, Section 6 Adverse Reactions: Clinical Trials Experience
The median time to on set of CRS symptoms and the median duration that it lasts are this. Information can be found here in the PI
what is 7 and 4 days?
PI: Section 5 Warning and Precautions
Name 3 warnings you will most likely find within the Carvykti PI and where these warnings will be found in the PI
What are:
PI sections: Black box warning, Section 5 Warnings and Precautions, Section 17 Patient counseling
This should be avoided prophylactically if the patient is going to receive Carvykti and this information is located here in the PI
What is Dexamethasone or other systemic steroids/corticosteroids
PI: Top of PI, Section 2 DOSAGE AND ADMINISTRATION
At the 2 year follow up, overall survival was achieved by this % of patients and this information is located here in the PI
What is 74%?
PI: Section 14 Clinical Studies
The median time to ICANS onset is this and its duration is this which can be found in this section in the PI
What is 8 days and 4 days.
PI: Section 5 Warnings and Precautions
These are the 3 most common drugs used to treat CRS
What is toci, anakinra and corticosteroids?
According to the Lancet article, this is the median turnaround time (defined as time from receipt to release of product) for CARVYKTI and where it can be found in the PI
What is 29 days and
PI section 14: clinical studies
Prior to every Carvykti administration this drug needs to be at the institution and you would find this information here in the PI
What is Tocilizumab?
Top of PI, Section 2 DOSAGE AND ADMINISTRATION, Section 5 Warning & precautions (CRS & REMs sections)
Stringent Complete Response rates increased from this % at ~1 yr to this % at 2 yrs
What is 67% to 83%
PI: Section 14 Clinical Studies
The majority of patients that experienced ICANS were 10% and this grade which is found here in the PI
what is grade 1?
PI: Section 5 Warnings and Precautions, Section 6 Adverse Reactions: Clinical Trials Experience
This is given to patients that have a low wbc, however in the setting of CRS it should be avoided
what is GCSF?
In ABECMA this animal is used, whereas for CARVYKTI this one was selected and this information would be located in this section of the PI
What are mice and llamas?( Go LLAMAS!)
What is in Section 11 Description & Section 12
Clinical Pharmacology MOA
Carvykti should be administered this many days after the START of the lymphodepletion and this information is located here in the PI
What is 5 to 7 days?
PI : Section 2 Dosage and Administration
The median time to first response was this, while the median time to best response is this and is found here in the PI
What is 1 month and 2.6 months?
PI: Section 14 Clinical Studies
Parkinsonism, Mental status change, tremor, somnolence, ataxia, confusional state are all examples of this
What are examples of neurotoxicity?
By the NCI CTCAE (version 5.0) you would be this grade if you had these symptoms
Temp 38 deg C & hypotension that responds to fluids & O2 at 3L NC
In the PI this information is located here.
What is grade 2?
PI Section: Section 2 Dosage and Administration: Management of Severe Adverse Reactions.
One monitoring or mitigation strategy that was implemented to minimize risk for patients receiving Carvykti.
What is:
-to allow investigators to give their choice of bridging therapy to reduce the risk of rapid progression during manufacturing.
-Early aggressive treatment of cytokine release syndrome and ICANS(handwriting assessments for early detection of NT symptoms: micrographia) and extended monitoring and reporting time for neurotoxicity up to 1 year after cilta-cel infusion
Carvykti (in CARTITUDE 1) is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received.... and the PI would say this here.
What is received 3 or more previous lines of therapy including PI, IMiD, and anti-CD38 therapy, or double refractory to PI and IMiD
PI: Top, Section 1 Indications and usage, Section 14 Clinical Studies
This % of patients were MRD negative of the 61 evaluated and is located here in the PI
What is 92%
PI: Section 14 Clinical Studies
At the 2 year update these were the new safety signals and information about this is located here in the PI
what are there are no new saftey signals!
PI: Section 6 Adverse Reactions: Clinical Trials Experience
A rare condition that can evolve from severe CRS is characterized by high serum ferritin, LDH, soluble CD25, cytokines and low fibrinogen
What is HLH/MAS