Johnson & Johnson : Janssen Announces U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse

News Release

Media Contacts:

Michelle Larkin

Phone: [phone]

Satu Glawe

Phone: [phone]

Investor Relations:

Jennifer McIntyre

Phone: [phone]

U.S. Medical Inquiries:

[phone]

Janssen Announces U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and

hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients

with Multiple Myeloma After First or Subsequent Relapse

DARZALEX FASPRO® is now the first and only subcutaneous anti-CD38 monoclonal antibody

approved in combination with pomalidomide and dexamethasone

July 12, 2021 (HORSHAM, P.A.) - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. The approval follows the regulatory submissionto the FDA in November 2020 and marks the sixth indication for DARZALEX FASPRO® in the treatment of multiple myeloma. Findings from the Phase 3 APOLLO study were presentedat the 2020 American Society of Hematology (ASH) Annual Meeting and were recently published in The Lancet Oncology.

"Clinical studies including APOLLO have continued to show the ability of daratumumab-based combination treatment regimens to significantly reduce the risk of progression in patients with multiple myeloma," said Meletios A. Dimopoulos, M.D.*, Professor and Chairman of the

1

Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and principal investigator. "With this approval, we are now able to combine pomalidomide and dexamethasone with a daratumumab subcutaneous option that can be administered in minutes rather than the hours needed for intravenous administration."

The APOLLO study met its primary endpoint of improved progression-free survival (PFS), demonstrating that DARZALEX FASPRO®-Pd significantly reduced the risk of progression or death by 37 percent, compared to Pd alone (hazard ratio, 0.63; 95 percent confidence interval [CI], 0.47- 0.85; P=0.0018).1 The median PFS for the DARZALEX FASPRO®-Pd arm vs. Pd arm was 12.4 vs.

6.9 months, respectively.1 Study findings additionally showed the rate of overall response to be significantly higher in DARZALEX FASPRO®-Pd compared to Pd alone (69 percent vs. 46 percent), as well as rates of complete response or better (25 percent vs. 4 percent) and very good partial response or better (51 percent vs. 20 percent).1 Additionally, more patients treated with DARZALEX FASPRO®-Pd showed a negative status for minimal residual disease than patients receiving Pd alone (9 percent vs. 2 percent).1

Permanent treatment discontinuation due to an adverse reaction occurred in 2 percent of patients who received DARZALEX FASPRO®-Pd. No adverse reactions resulting in permanent discontinuation occurred in more than 1 patient. The most common adverse reactions (≥20 percent) were fatigue, pneumonia, upper respiratory tract infection, and diarrhea. Serious adverse reactions occurred in 50 percent of patients who received DARZALEX FASPRO®-Pd. The most frequent serious adverse reactions in >5 percent of patients who received DARZALEX FASPRO®-Pd were pneumonia (15 percent) and lower respiratory tract infection (12 percent). Fatal adverse reactions occurred in 7 percent of patients who received DARZALEX FASPRO®-Pd.

"We are focused on the continued development of DARZALEX FASPRO and advancing this innovative therapy for patients who are in need of additional treatment options," said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. "Today's approval further distinguishes DARZALEX FASPRO in the treatment of multiple myeloma as the first and only subcutaneously administered anti-CD38 monoclonal antibody approved in combination with the widely used pomalidomide and dexamethasone regimen."

About the APOLLO StudyError! Bookmark not defined.

2

APOLLO (NCT03180736) is an ongoing multicenter, Phase 3, randomized, open-label study comparing DARZALEX FASPRO®/ daratumumab SC in combination with pomalidomide and low-dose dexamethasone with pomalidomide and low-dose dexamethasone alone in patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen, have received both lenalidomide and a proteasome inhibitor, and have demonstrated disease progression. The study enrolled 304 participants. The primary endpoint is PFS. Secondary endpoints include rates of overall response (ORR), very good partial response (VGPR) or better, complete response (CR) or better, and duration of response.

About DARZALEX FASPRO®

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered into a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. DARZALEX FASPRO® is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma and now AL amyloidosis. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.

DARZALEX FASPRO® is indicated for the treatment of adult patients with multiple myeloma:

• in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
• in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
• in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
• in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
• in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteosome inhibitor
• as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent

DARZALEX FASPRO® in combination with bortezomib, cyclophosphamide, and dexamethasone is indicated for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.

3

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Limitations of Use

DARZALEX FASPRO® is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

Full prescribing information for DARZALEX FASPRO® is available here.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.2,3 When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2021, it is estimated that more than 34,000 people will be diagnosed and close to 12,500 will die from the disease in the U.S.2,4 While some patients with multiple myeloma have no symptoms, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.4

DARZALEX FASPRO® IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

DARZALEX FASPRO® is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase or any of the components of the formulation.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Other Administration Reactions2

Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO®. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO®.

Systemic Reactions

In a pooled safety population of 832 patients with multiple myeloma (N=639) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO® as monotherapy or in combination, 9% of

4

patients experienced a systemic administration-related reaction (Grade 2: 3.5%, Grade 3: 0.8%). Systemic administration-related reactions occurred in 8% of patients with the first injection, 0.4% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 3.2 hours (range: 9 minutes to 3.5 days). Of the 129 systemic administration-related reactions that occurred in 74 patients, 110 (85%) occurred on the day of DARZALEX FASPRO® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients.

Severe reactions included hypoxia, dyspnea, hypertension and tachycardia. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritis, chills, vomiting, nausea, and hypotension.

Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO®. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.

Local Reactions

In this pooled safety population, injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 0.6%. The most frequent (>1%) injection-site reaction was injection site erythema. These local reactions occurred a median of 5.5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO®. Monitor for local reactions and consider symptomatic management.

Cardiac Toxicity in Patients with Light Chain (AL) Amyloidosis2

Serious or fatal cardiac adverse reactions occurred in patients with light chain (AL) amyloidosis who received DARZALEX FASPRO® in combination with bortezomib, cyclophosphamide and dexamethasone. Serious cardiac disorders occurred in 16% and fatal cardiac disorders occurred in 10% of patients. Patients with NYHA Class IIIA or Mayo Stage IIIA disease may be at greater risk. Patients with NYHA Class IIIB or IV disease were not studied. Monitor patients with cardiac involvement of light chain (AL) amyloidosis more frequently for cardiac adverse reactions and administer supportive care as appropriate.

5