On May 17, 2017 ArQule, Inc. (Nasdaq: ARQL) reported that data from the phase 1/2 trial in intrahepatic cholangiocarcinoma (iCCA) with fibroblast growth factor receptor (FGFR) inhibitor, ARQ 087, will be presented on June 3, 2017 at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, ArQule, MAY 17, 2017, View Source [SID1234519181]). The presentation will include an analysis of iCCA patients with FGFR2 fusions. ARQ 087 is a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family.

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A registrational phase 3 trial with ARQ 087 in second-line iCCA FGFR2 fusion positive patients is planned to begin in the third quarter of 2017. The company has been granted orphan drug designation by the U.S. Food and Drug Administration and European Medicines Agency for ARQ 087 in this indication.

The company will also present at ASCO (Free ASCO Whitepaper) final data from the completed Tivantinib METIV-HCC phase 3 trial for hepatocellular carcinoma.

Data will also be presented for the company sponsored ARQ 092 phase 1b trial in combination with carboplatin plus paclitaxel for oncology, and for the University of Texas Southwest sponsored ARQ 761 phase 1 trial cancer for cell necrosis.

Presentation Details

Saturday, June 3, 2017: Gastrointestinal (Noncolorectal) Cancer

ARQ 087
Abstract 4017/Poster Board: #9
ARQ 087, an oral pan-Fibroblast Growth Factor Receptor (FGFR) inhibitor, in patients (pts) with advanced intrahepatic cholangiocarcinoma (iCCA) with FGFR2 genetic aberrations.
Poster Session
Location: Hall A, 8:00 AM – 11:30 AM CT
Poster Discussion Session
Location: Hall D2, 4:45 PM – 6:00 PM CT

Sunday, June 4, 2017: Gastrointestinal (Noncolorectal) Cancer

Tivantinib (ARQ 197)
Abstract 4000
Second-line tivantinib (ARQ 197) vs placebo in patients (Pts) with MET-high hepatocellular carcinoma (HCC): Results of the METIV-HCC phase III trial.
Oral Abstract Session
Location: Hall D2, 8:00 AM – 8:12 AM CT

Monday, June 5, 2017: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics

ARQ 092
Abstract 2524/Poster Board #16
Results of a phase Ib study of ARQ 092 in combination with carboplatin (C) plus paclitaxel (P), or with P in patients (pts) with solid tumors.
Poster Session
Location: Hall A, 8:00 AM – 11:30 AM CT

ARQ 761
Abstract 2517/ Poster Board #9
Phase 1 study of ARQ 761, a β-lapachone analog that promotes NQO1-mediated programmed cancer cell necrosis.
Poster Session
Location: Hall A, 8:00 AM – 11:30 AM CT
Poster Discussion Session
Location: Arie Crown Theater, 11:30 AM – 12:45 PM CT

About Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC)1. Depending on the anatomic location, CCA is classified as intrahepatic (iCCA), perihilar (pCCA), and extrahepatic (eCCA). iCCA originates from the intrahepatic biliary ductal system and forms an intrahepatic mass. The average age adjusted incidence rate for iCCA is approximately one in 100,000 per year in the United States and Europe2,3.

About FGFR and ARQ 087

ARQ 087 is a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor ("FGFR") family with demonstrated efficacy in FGFR2 genetic alterations. The FGFR pathway is disrupted in several ways in human cancer, thus providing numerous therapeutic targets for an inhibitor of this pathway. ARQ 087 has demonstrated in vivo inhibition of tumor growth and downstream signaling in tumors whose growth is driven by FGFR targets.

Signals of single agent activity with this drug were observed in phase 1a testing. Phase 1b expansion cohorts with ARQ 087 include patients with cholangiocarcinoma and adrenocortical tumors, as well as those with FGFR translocations, amplifications and mutations. Clinical development of ARQ 087 advanced into phase 2 for intrahepatic cholangiocarcinoma (iCCA) in patients with FGFR2 fusions following the observation of two confirmed responses in this patient population in the phase 1 portion of the program, and a phase 3 registrational trial is planned to begin in the third quarter of 2017 in this same patient population.

About the AKT Pathway and ARQ 092

ARQ 092 is an orally bioavailable, selective small molecule inhibitor of the AKT kinases. The AKT pathway when abnormally activated is implicated in multiple oncogenic processes such as cell proliferation and apoptosis. This pathway has emerged as a target of potential therapeutic relevance for compounds that inhibit its activity, which has been linked to a variety of cancers as well as to select non-oncology indications.

Dysregulation of AKT is also a driver of certain rare proliferative disorders. For example, the E17K mutation of AKT1 causes Proteus syndrome, a rare non-cancerous segmental overgrowth disorder, and the analogous PIK3CA-Related Overgrowth Spectrum (PROS) is caused by genetic alterations in the PI3K pathway. ARQ 092 has been shown preclinically and clinically to inhibit AKT and PI3K cell signaling and therefore may provide the potential for much-needed treatment options for patients with these diseases.

ARQ 092, the lead compound in ArQule’s AKT program, has completed phase 1a clinical testing and has advanced into phase 1b expansion testing in cohorts of patients with endometrial cancer, lymphomas and tumors harboring either AKT or PI3K mutations. A company sponsored phase 1/2 trial is being conducted in the U.S. and E.U. for Overgrowth Diseases, including PROS and Proteus syndrome. ARQ 092 is also in a phase 1 trial being conducted by the NIH for Proteus syndrome. Collaborators are exploring in preclinical testing other indications for ARQ 092, including sickle cell disease.

On May 17, 2017 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported the presentation of two abstracts at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, 2017 in Chicago (Press release, CytRx, MAY 17, 2017, View Source [SID1234519178]). The first is an oral presentation featuring updated and more detailed results from the Company’s global Phase 3 clinical trial evaluating aldoxorubicin versus investigator’s choice in patients with relapsed and refractory soft tissue sarcomas (STS). The other is a poster presentation describing updated data from an ongoing Phase 1/2 clinical trial combining aldoxorubicin with ifosfamide/mesna (I-M) in first- and second-line STS.

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"In addition to the significantly prolonged progression-free survival achieved by both North American and L-sarcoma patients, the data presented at ASCO (Free ASCO Whitepaper) this year demonstrate that, unlike any other drugs in this class, aldoxorubicin can be dosed continuously with minimal to no cardiotoxicity," commented Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, California, and Principal Investigator for the Phase 3 trial. "Another distinct advantage is its ability to be administered to patients who have already been treated with doxorubicin. Taken together, these findings support aldoxorubicin’s potential as a superior anthracycline treatment for patients suffering with these highly complex and difficult to treat types of cancer."

Daniel Levitt, M.D., Ph.D., Chief Operating Officer and Chief Medical Officer of CytRx, commented, "The data from both of these important clinical trials evaluating aldoxorubicin in sarcomas, along with our several other completed clinical and preclinical studies, will form the basis of our planned New Drug Application submission to the U.S. Food and Drug Administration, and we are pleased to share these more mature and detailed results in this peer-reviewed forum with the medical and scientific communities."

Details for the presentations at ASCO (Free ASCO Whitepaper) 2017:

Oral Presentation

Title: Phase III study of aldoxorubicin vs investigators’ choice as treatment for relapsed/refractory soft tissue sarcomas
Presenter: Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, and Principal Investigator
Abstract #: 11000
Session Title: Oral Abstract Session: Sarcoma
Location: S100bc
Date and Time: Friday, June 2, 2017; 3:00pm-6:00pm CT
Summary: This multicenter, randomized, open-label Phase 3 trial enrolled 433 patients at 79 sites. The data summarized here are as of August 2016. In patients with leiomyosarcoma and liposarcoma (n=246), aldoxorubicin demonstrated median progression-free survival (PFS) of 5.32 months, compared to a median PFS of 2.96 months for investigator’s choice therapy, a statistically significant improvement of 2.36 months (p=0.007; hazard ratio (HR)=0.62, 95% CI 0.44-0.88), representing a 38% reduction in the risk of tumor progression. In patients treated in North America plus Australia (n=312), aldoxorubicin demonstrated a median PFS of 4.21 months, compared to a median PFS of 2.96 months for investigator’s choice therapy, a statistically significant improvement of 1.25 months (p=0.023, HR=0.71, 95% CI 0.53-0.96). In the overall intent to treat (ITT) trial population (n=433), aldoxorubicin performed better than investigator’s choice demonstrating a median PFS of 4.11 months, compared to a median PFS of 2.96 months for investigator’s choice therapy, narrowly missing statistical significance (p=0.087; HR=0.81, 95% CI 0.64-1.03). All responses in this study were determined by an independent, blinded central lab assessment of scans.

Key safety findings included that aldoxorubicin caused no clinically significant cardiac, renal, or hepatic toxicities. Aldoxorubicin administered at 350mg/m2 per cycle showed no cardiotoxicity up to 40 cycles. Importantly, left ventricular ejection fraction (LVEF) below 50% of expected values were reported in 4.2% of patients treated with aldoxorubicin, compared to 19.1% for patients receiving investigator’s choice. Additionally, ≥20% decreases in LVEF from baseline were reported in 3.8% of patients treated with aldoxorubicin, compared to 8.5% for patients receiving investigator’s choice. For the global trial population, the most commonly reported (≥10%) Grade ≥3 adverse events were neutropenia, anemia, febrile neutropenia, stomatitis and decreased white blood cell count, and were manageable with standard supportive care. The non-cardiac Grade ≥3 adverse events associated with aldoxorubicin were similar to doxorubicin despite exposure up to 3-4 times the standard doxorubicin dose.

Updated data relating to the trials other secondary endpoints, including objective response rate (ORR), disease control rate (DCR), overall survival, and other safety parameters were in line with what has previously been reported by CytRx and will be included in the oral presentation being given at ASCO (Free ASCO Whitepaper) 2017.

Following conclusion of Dr. Chawla’s presentation, a PDF copy of the oral presentation slides will be available at View Source

Poster Presentation

Title: Administration of aldoxorubicin and 14 days continuous infusion of ifosfamide/Mesna in metastatic or locally advanced sarcomas
Presenter: Frederick C. Eilber, M.D., Director of the UCLA Sarcoma Translational Research Program within the Jonsson Comprehensive Cancer Center
Abstract #: 11051
Session Title: Poster Session: Sarcoma
Location: Hall A
Poster board#: 374
Date and Time: Sunday, June 4, 2017; 8:00am-11:30am CT
Summary: This ongoing open-label Phase 1/2 clinical trial is designed to assess the preliminary safety and activity of aldoxorubicin plus I-M as a first- or second-line treatment in patients with STS. Patients were administered 1 of 2 dose levels of aldoxorubicin (170mg/m2 or 250mg/m2 [125mg/m2 or 185mg/m2 doxorubicin equivalent]) on Day 1, then I-M (1g/m2 of each per day) was administered for up to 14 days as a continuous infusion. Chemotherapy cycles were repeated at 28 day intervals, but I-M was limited to a maximum of 6 cycles to avoid cumulative bone marrow toxicity. Aldoxorubicin was continued per investigator decision in either responding or stable disease (SD) patients. Patients were followed for tumor response by CT scans and echocardiogram for cardiac toxicity every 8 weeks along with standard labs.

Of the 44 evaluable patients as of May 10, 2017, 16 patients (36%) achieved a partial response (PR), 25 patients (57%) achieved SD, with 20 patients (45%) achieving SD for ≥4 months, for an overall disease control rate (DCR) of 82% (PR+SD≥4). Twenty-two of 44 (50%) patients received at least 6 cycles of aldoxorubicin (>1,300 mg/m2 cumulative doxorubicin equivalent). As of the data cutoff date, the median PFS had not been reached. The most commonly reported Grade ≥3 adverse event (AEs; >20%) were neutropenia and anemia. Reported serious adverse events (SAEs) included febrile neutropenia (14%, n=6), anemia (5%, n=2), thrombocytopenia (2%, n=1), stomatitis (2%, n=1) and pyrexia (2%, n=1). No clinically significant cardiotoxicity has been observed and no patients had a clinically significant decrease in LVEF or QTc prolongation, despite administration of median cumulative doses of doxorubicin equivalents of 1364-1965mg/m2. No treatment related deaths occurred. These results support the thesis that aldoxorubicin can be administered safely and for prolonged periods with continuous infusion I-M and achieves high response rates and SD, with substantial tumor necrosis. Based on these results, the decision was made to stop further aldoxorubicin dose escalation and continue to enroll only in the 250mg/m2 cohort.

Following conclusion of the poster presentation, a PDF copy of the poster will be available at View Source

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue. It can arise anywhere in the body at any age. STS remains a high unmet medical need because of the difficulty in treating the more than 50 types of this aggressive cancer. According to the American Cancer Society, in 2016 more than 12,300 new cases were diagnosed in the U.S. and approximately 5,000 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About Aldoxorubicin

Aldoxorubicin is a rationally-engineered cytotoxic which combines doxorubicin, a widely used chemotherapeutic agent, with a novel linker molecule that binds directly and specifically to circulating albumin, the most abundant protein in the bloodstream. Protein-hungry tumors concentrate albumin, which facilitates the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. Typically, doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Using this acid-sensitive linker technology, aldoxorubicin delivers greater doses of doxorubicin (3 ½ to 4 times). To date, there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 6,500 mg/m2 of doxorubicin equivalents. Aldoxorubicin is the first-ever single agent to show superiority over doxorubicin in a randomized clinical trial in first-line STS.

On May 17, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that its partner Janssen Biotech, Inc. plans to start four new studies of daratumumab in multiple myeloma and amyloidosis (Press release, Genmab, MAY 17, 2017, View Source [SID1234519177]).

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The studies described below are currently planned to start between the second half of 2017 and the first quarter of 2018 and may be subject to change. DARZALEX is being developed under an August 2012 agreement in which Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize the product.
Phase III study of daratumumab in smoldering multiple myeloma
Phase III study comparing the subcutaneous and intravenous administration of daratumumab in relapsed and refractory multiple myeloma
Phase III study of daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone for amyloidosis

Phase II study of subcutaneous daratumumab in combination with standard of care regimens for frontline and relapsed multiple myeloma

The plans for the new studies were announced at Johnson & Johnson’s Pharmaceutical Business Review today.
"Janssen’s expansive development plans for daratumumab emphasize the commitment to test daratumumab broadly in many different clinical settings, which hopefully results in better treatment options for patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy and as a monotherapy for the treatment of patients with multiple myeloma 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.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy and for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. For more information, visit www.DARZALEX.com .

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. Five Phase III clinical studies with daratumumab in relapsed and frontline multiple myeloma settings are currently ongoing, and additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma, NK/T-cell lymphoma, amyloidosis, myelodysplastic syndromes and solid tumors. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.

On May 17, 2017 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported an upcoming poster presentation for its lead product candidate, CX-072, a PD-L1 targeting Probody therapeutic for the treatment of cancer, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 2-6, 2017 in Chicago, Illinois (Press release, CytomX Therapeutics, MAY 17, 2017, View Source [SID1234519175]).

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"The occurrence of immune-related adverse events is emerging as the Achilles’ heel of cancer immunotherapy," said Rachel W. Humphrey, M.D., chief medical officer of CytomX Therapeutics. "Our recently initiated Phase 1/2 clinical trial, part of our umbrella PROCLAIM program, is investigating the potential of our differentiated, anti-PD-L1 Probody therapeutic, CX-072, to reduce overactivation of the immune system outside of the tumor, while remaining active as a single-agent and in combination therapy. This poster presentation at ASCO (Free ASCO Whitepaper) will review the design and objectives of this ongoing study."

Abstract Information

Title: PROCLAIM-001: A first-in-human trial to assess tolerability of the protease-activatable anti-PD-L1 Probody CX-072 in solid tumors and lymphomas
Author: Alexander I. Spira, M.D., Ph.D., F.A.C.P., Medical Oncologist and Director, Virginia Cancer Specialists Research Institute and Oncology Research
Session: Developmental Therapeutics—Immunotherapy
Date: Monday, June 5, 2017
Time: 8:00 a.m. – 11:30 a.m.
Location: Hall A
Abstract: TPS3107
About the PROCLAIM-CX-072 Trial
PROCLAIM-CX-072 is the first clinical trial under the international umbrella program, PROCLAIM. The trial is an open-label, dose-finding Phase 1/2 study evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib). As part of the study, CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:

Tolerability: Demonstrate that CX-072 is well tolerated in patients and potentially improves safety, particularly in the combination setting.
Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.
Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical studies.
More information about the trial is available at clinicaltrials.gov.

On May 17, 2017 Johnson & Johnson (NYSE: JNJ) and its Janssen Pharmaceutical Companies reported it will announce plans to launch or file for regulatory approval more than 10 new products with blockbuster potential between 2017 and 2021, as well as 50-plus line extensions of existing and new medicines that will bring the company’s transformational medicines to an even broader patient population (Press release, Johnson & Johnson, MAY 17, 2017, View Source [SID1234519174]). The company will also share its plans to continue driving sustainable growth by leveraging its strong portfolio of core blockbuster products, the industry-leading productivity of its innovation model, and the pending acquisition of Swiss-based biotech company Actelion.

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"With a growing core business of differentiated medicines and a strong line-up of innovative products expected to launch or file over the next five years, we are leading the industry in advancing the health of patients around the world," said Alex Gorsky, Chairman and Chief Executive Officer. "Our pharmaceutical business will continue to be a significant driver of innovation and growth for Johnson & Johnson. With our proven global commercial capabilities and robust pipeline, we are well-positioned to continue delivering strong, long-term, sustainable growth."

An industry leader in research productivity, Janssen has received US FDA approval for 11 new molecular entities (NMEs) since 2011. With a portfolio focused on five core therapeutic areas – Immunology, Infectious Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism, and Oncology – the Pharmaceutical segment of Johnson & Johnson is delivering transformational new medicines for unmet medical needs worldwide, and expects to add a sixth therapeutic area in Pulmonary Arterial Hypertension upon the completion of the acquisition of Actelion, which is expected to close by the end of the second quarter.

In 2016, the company filed two NMEs that it anticipates will be approved and launched later this year:

guselkumab for psoriasis; and
sirukumab for rheumatoid arthritis.
Additional late-stage blockbuster products1 projected to file for regulatory approvals between 2017 and 2021, include:

apalutamide (ARN-509) for pre-metastatic prostate cancer;
esketamine for treatment-resistant depression;
talacotuzumab (CSL362) for acute myeloid leukemia;
erdafitinib (FGFR Inhibitor) for solid tumors;
niraparib for prostate cancer;
imetelstat for myelofibrosis;
pimodivir (JNJ-3872) for influenza A;
lumicitabine (JNJ-1575) for respiratory syncytial virus (RSV) infection; and,
JNJ-7922 (orexin-2 antagonist) for adjunctive treatment for major depressive disorder.