ty-four percent of patients had been treated withprior anti PD-L1/PD-1 therapy.
Efficacy results are summarized in Table 7 and Table 8. Overall response rate was 32.2%. Respondersincluded patients who had previously not responded to anti PD-L1/PD-1 therapy.
Table 7: Efficacy Results
Endpoint
BIRCa assessment
N=87
ORR (95% CI) 32.2% (22.4, 42.0)
Complete response (CR) 2.3%
Partial response (PR) 29.9%
Median DoR in months (95% CI) 5.4 (4.2, 6.9)
a BIRC: Blinded Independent Review Committee
ORR = CR + PR
CI = Confidence Interval
Table 8: Efficacy Results by FGFR Genetic Alteration
BIRCa assessment
FGFR3 Point Mutation N=64
ORR (95% CI) 40.6% (28.6, 52.7)
FGFR3 Fusion b, c N=18
ORR (95% CI) 11.1% (0, 25.6)
FGFR2 Fusion c N=6
ORR 0
a BIRC: Blinded Independent Review Committee
b Both responders had FGFR3-TACC3_V1 fusion
c One patient with a FGFR2-CASP7/FGFR3-TACC3_V3 fusion is reported in both FGFR2 fusion and FGFR3 fusion above
ORR = CR + PR
CI = Confidence Interval
16 HOW SUPPLIED/STORAGE AND HANDLING
BALVERSA™ (erdafitinib) tablets are available in the strengths and packages listed below:
•3 mg tablets: Yellow, round biconvex, film-coated, debossed with “3” on one side and “EF” on
the other side.
− Bottle of 56-tablets with child resistant closure (NDC 59676-030-56).
− Bottle of 84-tablets with child resistant closure (NDC 59676-030-84).
− Two dose pack wallets of 28-tablets each (NDC 59676-030-22) in a box of 56-tablets
(NDC 59676-030-55).
− Two dose pack wallets of 42-tablets each (NDC 59676-030-44) in a box of 84-tablets
(NDC 59676-030-88).
•4 mg tablets: Orange, round biconvex, film-coated, debossed with “4” on one side and “EF” on
the other side.
− Bottle of 28-tablets with child resistant closure (NDC 59676-040-28).
− Bottle of 56-tablets with child resistant closure (NDC 59676-040-56).
− One starter pack wallet of 14-tablets in a box (NDC 59676-040-14).
− One dose pack wallet of 28-tablets in a box (NDC 59676-040-22).
− Two dose pack wallets of 28-tablets each (NDC 59676-040-22) in a box of 56-tablets(NDC 59676-040-55).
•5 mg tablets: Brown, round biconvex, film-coated, debossed with “5” on one side and “EF” on
the other side.
−Bottle of 28-tablets with child resistant closure (NDC 59676-050-28).
−One dose pack wallet of 28-tablets in a box (NDC 59676-050-22).Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see
USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
FGFR genetic alterations: Advise patients that evidence of a susceptible FGFR3 or FGFR2 mutation orgene fusion within the tumor specimen is necessary to identify patients for whom treatment is indicated[see Dosage and Administration (2.1)].
Ocular disorders: Advise patients to contact their healthcare provider if they experience any visualchanges [see Warnings and Precautions (5.1)]. In order to prevent or treat dry eyes, advise patients touse artificial tear substitutes, hydrating or lubricating eye gels or ointments frequently, at least every 2ho
