Johnson & Johnson : Janssen Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of BALVERSA® (erdafitinib) for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations

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Janssen Submits Supplemental New Drug Application to the U.S. Food and Drug

Administration Seeking Full Approval of BALVERSA® (erdafitinib) for the

Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma

and Selected Fibroblast Growth Factor Receptor Gene Alterations

Submission Based on Confirmatory Data from Cohort 1 of the Phase 3 THOR Study, Which Showed a 36 Percent Reduction in the Risk of Death in Patients Treated with BALVERSA® Versus Chemotherapy

RARITAN, N.J., August 29, 2023 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking full approval of BALVERSA® (erdafitinib), a kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations, and progressed during or following at least one line of a programmed death receptor-1(PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy.1

BALVERSA® received Breakthrough Therapy Designation from the U.S. FDA in 2018 and received accelerated approvalin 2019 for the treatment of adults with locally advanced or mUC which has susceptible FGFR3 or FGFR2 genetic alterations and who have progressed

during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. The sNDA submission for BALVERSA® is intended to satisfy the regulatory requirements to confirm the clinical benefit of BALVERSA® based on the randomized data from Cohort 1 of the Phase 3 THOR study.2

"BALVERSA continues to generate promising clinical findings for patients with FGFR-altered metastatic urothelial cancer, who often face poor disease outcomes," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "Through the ongoing development of this targeted therapy, we are committed to transforming bladder cancer treatment to positively impact the lives of patients."

The sNDA is based upon data from Cohort 1 of the randomized, controlled, open-label, multicenter Phase 3 THOR (NCT03390504) study evaluating the efficacy and safety of BALVERSA®. The study met its primary endpoint of overall survival (OS), with patients who received BALVERSA® achieving a median OS of over one year at the prespecified interim analysis data cutoff. 2

As the interim results met the predefined criteria for superiority of treatment with BALVERSA® over chemotherapy, the independent data safety monitoring committee recommended that the study be stopped, and that patients randomized to chemotherapy be offered the opportunity to cross over to BALVERSA®. The safety profile of BALVERSA® observed in THOR was consistent with the known safety profile of BALVERSA® in mUC. Results from Cohort 1 were presentedin a Late-Breaking Presentation Session (Abstract # LBA4619) at the 2023 American Society of Clinical OncologyAnnual Meeting.3

The current full prescribing information is available at www.BALVERSA.com.

About THOR

THOR (NCT03390504) is a Phase 3 randomized, open-label, multicenter study evaluating the efficacy and safety of BALVERSA®. All patients included in the study had metastatic or unresectable UC, with selected FGFR genetic alterations, and showed disease progression during or after one or two prior lines of treatment. The study compared BALVERSA® in two cohorts; BALVERSA® versus standard of care chemotherapy (investigators choice of docetaxel or vinflunine) after at least one line of treatment including an anti-programmed death (ligand)

1 (PD-[L]1) agent (Cohort 1); and BALVERSA® compared to pembrolizumab after one prior treatment not containing an anti-PD-(L)1 agent (Cohort 2). The trial consists of screening, a treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment) and a post- treatment follow-up (from end-of-treatment to participant's death, withdraws consent, lost to follow-up study completion for the respective cohort, whichever comes first). A long-term extension period is planned for after the clinical cutoff date is achieved for the final analysis of each cohort for patients who continue to benefit from the study intervention. The primary endpoint of the study is OS; progression free survival (PFS), objective response rate (ORR), duration of response (DOR), patient-reported outcomes, safety and pharmacokinetics (PK) are secondary endpoints. Results from Cohort 1 were presented at the 2023 ASCO Annual Meeting earlier this year; findings from Cohort 2 will be presented at an upcoming medical meeting. 2,3

About BALVERSA®

BALVERSA® (erdafitinib) is a once-daily, oral FGFR kinase inhibitor that is approved by the U.S. FDA for the treatment of adults with locally advanced or mUC that have susceptible FGFR3 or FGFR2 genetic alterations and have progressed during or following at least one line of platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Patients are selected for therapy based on an FDA- approved companion diagnostic for BALVERSA®. Information on FDA-approved tests for the detection of FGFR genetic alterations in urothelial cancer is available at: http://www.fda.gov/CompanionDiagnostics. This indication is approved under accelerated approval based on tumor response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1,4

In addition to the Phase 3 THOR study, BALVERSA® is being studied in the Phase 2 THOR-2/BLC2003 study (NCT04172675) study examining BALVERSA® versus investigator choice of intravesical chemotherapy in participants who received Bacillus Calmette-Guérin and recurred with high risk non-muscle-invasive bladder cancer and the Phase 1 study (NCT05316155) investigating BALVERSA® in patients with non-muscle invasive or muscle invasive bladder cancer with select FGFR alterations, given via the TARIS intravesical drug delivery system (TAR-210), which is designed to release BALVERSA® in the bladder to treat localized bladder cancer, while reducing systemic toxicities.1,2,5

6,10,11,12,13

In 2008, Janssen Pharmaceutica NV entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialize BALVERSA®.

For more information, visit www.BALVERSA.com.

About Urothelial Carcinoma

Urothelial carcinoma, also known as transitional cell carcinoma, starts in the innermost lining of the bladder.6 It is the most common and frequent form of bladder cancer, representing more than 90 percent of all bladder cancers.7 Metastatic or unresectable disease is identified in approximately 20 percent of patients presenting with urothelial cancer, or an estimated five to eight percent of all bladder cancers. Approximately one in five patients (20 percent) diagnosed with mUC have an FGFR genetic alteration.8,9 Fibroblast growth factor receptors are a family of receptor tyrosine kinases that can be activated by genetic alterations in a variety of tumor types, and these alterations may lead to increased tumor cell growth and

survival. Select FGFR genetic alterations can be detected through an FDA-approved companion diagnostic. The five-year survival rate for patients with Stage IV metastatic bladder cancer that has spread to distant parts of the body is currently eight percent.14

BALVERSA® IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Ocular Disorders - BALVERSA® can cause ocular disorders, including central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED) resulting in visual field defect.

CSR/RPED was reported in 25% of patients treated with BALVERSA®, with a median time to first onset of 50 days. Grade 3 CSR/RPED, involving central field of vision, was reported in 3% of patients. CSR/RPED resolved in 13% of patients and was ongoing in 13% of patients at the study cutoff. CSR/RPED led to dose interruptions and reductions in 9% and 14% of patients, respectively, and 3% of patients discontinued BALVERSA®. Dry eye symptoms occurred in 28% of patients during treatment with BALVERSA® and were Grade 3 in 6% of patients. All patients should receive dry eye prophylaxis with ocular demulcents as needed.

Perform monthly ophthalmological examinations during the first 4 months of treatment and every 3 months afterwards, and urgently at any time for visual symptoms. Ophthalmological examination should include assessment of visual acuity, slit lamp examination, fundoscopy, and optical coherence tomography. Withhold BALVERSA® when CSR occurs and permanently discontinue if it does not resolve within 4 weeks or if Grade 4 in severity. For ocular adverse reactions, follow the dose modification guidelines [see Dosage and Administration (2.3)].

Hyperphosphatemia and Soft Tissue Mineralization - BALVERSA® can cause hyperphosphatemia leading to soft tissue mineralization, cutaneous calcinosis, non-uremiccalciphylaxis and vascular calcification. Increases in phosphate levels are a pharmacodynamic effect of BALVERSA® [see Pharmacodynamics (12.2)]. Hyperphosphatemia was reported as adverse reaction in 76% of patients treated with BALVERSA®. The median onset time for any grade event of hyperphosphatemia was 20 days (range: 8-116)after initiating BALVERSA®. Thirty-twopercent of patients received phosphate binders during treatment with BALVERSA®. Cutaneous calcinosis, non-uremiccalciphylaxis and vascular calcification have been observed in 0.3% of patients treated with BALVERSA®.

Monitor for hyperphosphatemia throughout treatment. In all patients, restrict phosphate intake to 600-800 mg daily. If serum phosphate is above 7.0 mg/dL, consider adding an oral phosphate binder until serum phosphate level returns to <5.5 mg/dL. Withhold, dose reduce, or permanently discontinue BALVERSA® based on duration and severity of hyperphosphatemia [see Dosage and Administration (2.3), Table 2: Dose Modifications for Adverse Reactions].

Embryo-FetalToxicity - Based on the mechanism of action and findings in animal reproduction studies, BALVERSA® can cause fetal harm when administered to a pregnant woman. In a rat embryo-fetal toxicity study, erdafitinib was embryotoxic and teratogenic at exposures less than the human exposures at all doses studied. Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during treatment with BALVERSA® and for one month after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with BALVERSA® and for one month after the last dose [see Use in Specific Populations (8.1, 8.3) and Clinical Pharmacology (12.1)].

Most common adverse reactions including laboratory abnormalities ≥20%: