April 12,2019 IND approval by FDA

On April 12, 2019 Wayshine Biopharm reported that it has received IND approval from FDA about its innovative experimental medicine WSD0922, a First-in-Class CNS penetrable EGFR/EGFRvIII inhibitor for the treatment of Glioblastoma, Anaplastic Astrocytoma and cancers with CNS metastasis patients (Press release, Wayshine Biopharm, APR 12, 2019, View Source [SID1234537799]). The WSD0922 program is under the sponsorship of Wayshine and the clinical trial, entitled "A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU" will be performed at Minnesota, Arizona and Florida, the three campuses of Mayo Clinic. Glioblastoma is the most aggressive malignant primary brain tumor in adults and is nearly always fatal. Treatment options for GBM are scarce and recurrence is inevitable. After recurrence, no standard treatment has been established. WSD0922 could be a potential game-changing program in treating GBM and other brain cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very pleased that the FDA has approved the application of IND, which is a significant development milestone in advancing our Portfolio," said Wei Zhong, Ph.D., CEO and Founder of Wayshine Biopharm. "WSD0922 is the first and only BBB penetrable EGFR/EGFRvIII inhibitor under development. The discovery of WSD0922 truly reflects our innovation and commitments and the clinical potential has been recognized and endorsed by the FDA, for this substantial unmet medical need. "

"If only one target can be picked for brain cancer, it’s EGFR/EGFRvIII." Comments from KOLs in Neuro-Oncology field.

"We make difference! WSD0922 is discovered and developed by Chinese scientists and the IND approval in US is a very important progress in its development. With the help from FDA and Mayo Clinic, we can definitely move this program forward quickly to benefit patients who are suffering Glioblastoma and the data generated from the study in cancer patients will significantly contribute to the brain cancer field." commented by Jinqiang Zhang, Ph.D., VP and co-founder at Wayshine.

Kitov Announces Key Milestone in FameWave Acquisition

On April 12, 2019 Kitov Pharma Ltd.(NASDAQ/TASE: KTOV), an innovative pharmaceutical company developing first-in-class combination oncology therapies, reported a key milestone in the acquisition of FameWave Ltd., following signature of a clinical collaboration agreement between FameWave and Bristol Myers Squibb (BMY) for their planned Phase 1/2 clinical trials to evaluate the combination of CM-24, a monoclonal antibody targeting the novel immune checkpoint carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1) with nivolumab (Opdivo), a PD-1 inhibitor, in patients with non-small cell lung cancer (NSCLC) (Press release, Kitov Pharmaceuticals , APR 12, 2019, View Source [SID1234535142]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We look forward to completing the acquisition of FameWave and advancing CM-24 studies in the clinic," said Isaac Israel, chief executive officer of Kitov. "Our goal is to assess the innovative combination of CM-24 with Opdivo In NSCLC patients. Since we believe CM-24 has great potential as a novel checkpoint inhibitor to be used in combination therapies to provide new options to address the significant unmet medical need in hard-to-treat cancers."

Preclinical studies have shown a strong synergetic anti-cancer effect using CM-24 in combination with a PD-1 antibody. Based on Kitov’s review of the initial Phase I dose ranging study of CM24 as a single agent, performed by Merck Sharpe & Dohme, Kitov plans to explore higher doses in order to reach receptor saturation,.

Kitov isacquiring FameWave, pending completion of certain additional closing conditions, including approval by the shareholders of Kitov of the acquisition.

Conference Call and Webcast Information:

The Company will host a conference call Monday, April 15, 2019, at 8:30 a.m. EDT to discuss the FameWave acquisition deal and new asset CM-24.

The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website. Please access the webcast and conference line dial-in at least 15 minutes ahead of the conference call to register. Conference ID: 13689863; U.S dial in: 877-705-6003; Israel dial in: 1 809 406 247; International dial in: 201-493-6725. Webcast: View Source

About CEACAM1 and CM-24

CM-24 is a humanized monoclonal antibody directed against carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1), an immune checkpoint protein belonging to the Human CEA (Carcino-Embryonic Antigen) protein family. Evidence has shown that CEACAM1 is expressed on tumor lymphocytes and is up-regulated in several cancer types. Preclinical studies have shown evidence that CM-24 enhances the cytotoxic activity of tumor-infiltrating lymphocytes (TILs) against various CEACAM1-positive tumor cell lines. CM-24 is being developed for multiple oncological indications according to the expression pattern of its target protein.

As part of the recently announced agreement for the acquisition of FameWave by Kitov, cCAM BioTherapeutics Ltd., a wholly owned subsidiary of Merck Sharp and Dohme Corp., known as "MSD" in Israel, has returned the rights to CM-24 to former cCAM shareholders and founders of FameWave, following an initial Phase 1 dose ranging study of CM-24 as single agent.

FameWave Announces Clinical Collaboration with Bristol Myers Squibb for the Planned Phase 1/2 Trial in Non-Small Cell Lung Cancer to Evaluate Immuno-Oncology Candidate CM-24 in Combination with Nivolumab (Opdivo®)

On April 12, 2019 FameWave Ltd. a privately held biopharmaceutical company developing CM-24, which is being acquired by Kitov Pharma Ltd. (NASDAQ/TASE: KTOV), reported the signing of a clinical collaboration with Bristol Myers Squibb Company (NYSE:BMY) to evaluate the combination of CM-24, FameWave’s monoclonal antibody targeting the novel immune checkpoint carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1), with nivolumab (Opdivo), a PD-1 inhibitor, in patients with non-small cell lung cancer (NSCLC) (Press release, Kitov Pharmaceuticals , APR 12, 2019, View Source [SID1234535123]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FameWave and Bristol Myers Squibb will coordinate on the protocol design for the Phase 1/2 clinical trial in a well-defined patient population with NSCLC. Under the terms of the agreement, FameWave will fund and sponsor the study and Bristol Myers Squibb will supply nivolumab.

"FameWave’s collaboration with Bristol-Myers Squibb, a global leader in immuno-oncology, is a crucial step to begin evaluation of CM-24 in combination with a PD-1 inhibitor," said Dr. Michael Schickler, chief executive officer of FameWave. "We look forward to evaluating CM-24 in NSCLC since we believe it has a great potential as a novel immune checkpoint to be used in combination therapies for a variety of hard-to-treat cancers."

About CEACAM1 and CM-24

CM-24 is a humanized monoclonal antibody directed against carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1), an immune checkpoint protein belonging to the Human CEA (Carcino-Embryonic Antigen) protein family. Evidence has shown that CEACAM1 is expressed on tumor lymphocytes and is up-regulated in several cancer types. Preclinical studies have shown evidence that CM-24 enhances the cytotoxic activity of tumor-infiltrating lymphocytes (TILs) against various CEACAM1-positive tumor cell lines. CM-24 is being developed for multiple oncological indications according to the expression pattern of its target protein.

As part of the recently announced agreement for the acquisition of FameWave by Kitov Pharma Ltd. (NASDAQ/TASE: KTOV), cCAM BioTherapeutics Ltd., a wholly owned subsidiary of Merck Sharp and Dohme Corp., known as "MSD" in Israel, is returning the rights to CM-24 to former cCAM shareholders and founders of FameWave, following an initial Phase 1 dose ranging study of CM-24 as single agent. Kitov’s acquisition of FameWave is pending completion of certain closing conditions, including FameWave entering this collaboration agreement for CM-24 with Bristol Myers Squibb.

BALVERSA™ (erdafitinib) Receives U.S. FDA Approval for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma with Certain FGFR Genetic Alterations

On April 12, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that BALVERSA (erdafitinib) received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible fibroblast growth factor receptor (FGFR)3 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.1 BALVERSA is the first FGFR kinase inhibitor approved by the FDA (Press release, Janssen Pharmaceuticals, APR 12, 2019, View Source [SID1234535119]). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1 Today’s approval follows FDA Breakthrough Therapy Designation in March 2018 and Priority Review Designation of the New Drug Application submitted in September 2018.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I’ve spent my career specializing in the care of patients with metastatic urothelial carcinoma and understand the need for new treatments for this disease," said Arlene O. Siefker-Radtke, M.D., professor of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, and lead study investigator. "BALVERSA is an important new therapy for this small subset of patients with urothelial carcinoma who, up until now, had limited treatment options."

BALVERSA, a once-daily oral FGFR kinase inhibitor, received accelerated approval based on results from a Phase 2 clinical trial (BLC2001, NCT02365597), a multicenter, open-label, single-arm study, of 87 patients with disease that had progressed on or after at least one prior chemotherapy and that had at least one of the following genetic alterations: FGFR3 gene mutations (R248C, S249C, G370C, Y373C) or FGFR gene fusions (FGFR3-TACC3, FGFR3-BAIAP2L1, FGFR2-BICC1, FGFR2-CASP7), as determined by a clinical trial assay performed at a central laboratory.1 The results demonstrated a 32.2 percent objective response rate (ORR) as assessed by Blinded Independent Review Committee (BIRC) [95% CI(22.4, 42.0)].1 Responders included patients who had previously not responded to anti PD-L1/PD-1 therapy.1 In the trial, ORR was defined as the percentage of patients with measurable lesions achieving a complete response (CR) [2.3 percent] or partial response (PR) [29.9 percent]1 to treatment using the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria, a standard way to measure how well a patient responds to treatment based on whether tumors shrink, stay the same, or get bigger as assessed per investigator.2 Results also showed a median duration of response (DoR) of 5.4 months [95% CI(4.2, 6.9)] in patients treated with BALVERSA.1There were no confirmed responses to BALVERSA in the FGFR2 fusion patient population (n=6).1 Data from the BLC2001 study were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting (Abstract #4503) and were recognized as a "Best of ASCO (Free ASCO Whitepaper)" selection.

Warnings and Precautions include Ocular Disorders, Hyperphosphatemia and Embryo-fetal Toxicity.1 The most common adverse reactions (ARs) including laboratory abnormalities >20% were phosphate increased (76%), stomatitis (56%), fatigue (54%), creatinine increased (52%), diarrhea (47%), dry mouth (45%), onycholysis (41%), alanine aminotransferase increased (41%), alkaline phosphatase increased (41%), sodium decreased (40%), decreased appetite (38%), albumin decreased (37%), dysgeusia (37%), hemoglobin decreased (35%), dry skin (34%), aspartate aminotransferase increased (30%), magnesium decreased (30%), dry eye (28%), alopecia (26%), palmar-plantar erythrodysesthesia syndrome (26%), constipation (28%), phosphate decreased (24%), abdominal pain (23%), calcium increased (22%), nausea (21%), and musculoskeletal pain (20%). The most common Grade 3 or greater ARs (>1%) were stomatitis (9%), nail dystrophy*, palmar-plantar erythrodysesthesia syndrome (6%), paronychia (3%), nail disorder*, keratitis^, onycholysis (10%*) and hyperphosphatemia. (*Included within onycholysis. ^Included within dry eye.)1

The FDA simultaneously approved a companion diagnostic for use with BALVERSA, the QIAGEN therascreen FGFR RGQ Reverse-transcription (RT)-polymerase chain reaction (PCR) Kit, which is the first PCR-based companion diagnostic approved to detect FGFR alterations. The therascreen FGFR test detects the presence of FGFR alterations in the tumor tissue of patients with mUC.1 If one or more of the genetic alterations or fusions are detected, the patient may be a candidate for treatment with BALVERSA. Information on FDA-approved tests for the detection of FGFR genetic alterations in urothelial carcinoma is available at: View Source

Janssen is offering BALVERSA and associated patient services through a single source specialty pharmacy provider, US Bioservices. This model is part of Janssen’s ongoing commitment to provide high-quality products, services, access, and support to healthcare professionals and patients.

"We recognize the significant unmet need that persists in the treatment of men and women diagnosed with this form of urothelial carcinoma, and we have worked expeditiously to develop BALVERSA for patients in close consultation with the FDA," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "We look forward to the continued development of BALVERSA to understand how this important new therapy may further inform the care of patients with metastatic urothelial carcinoma and its investigational use in other cancers where FGFR alterations may be present in the future."

"The FDA approval of BALVERSA represents our commitment to deliver much-needed therapies for devastating diseases, including metastatic urothelial carcinoma where there is a lack of therapeutic options," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "We are also pleased to see the simultaneous FDA approval of a companion diagnostic with BALVERSA, which will offer a more personalized approach to therapy for healthcare professionals to treat their patients."

Full prescribing information will be available at www.BALVERSA.com.

About Urothelial Carcinoma
Urothelial carcinoma, also known as transitional cell carcinoma, starts in the innermost lining of the bladder.3 It is the most common and frequent form of bladder cancer, representing more than 90 percent of all bladder cancers.4 About one in five patients with mUC have a FGFR genetic alteration.5,6 FGFRs are a family of receptor tyrosine kinases which can be activated by genetic alterations in a variety of tumor types, and these alterations may lead to increased tumor cell growth and survival.7 BALVERSA is approved specifically for the treatment of patients with mUC harboring FGFR3 or FGFR2 genetic alterations. In the U.S., it is estimated that up to 3,000 people with urothelial carcinoma will test FGFR positive on an annual basis.5,6,8,9 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 five percent.10

About BALVERSA (erdafitinib)
BALVERSA (erdafitinib) is a once-daily, oral fibroblast growth factor receptor (FGFR) kinase inhibitor indicated for the treatment of adults with locally advanced or metastatic urothelial carcinoma (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.1 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

The pivotal multicenter, open-label Phase 2 BLC2001 (NCT02365597) clinical trial evaluated the efficacy and safety of BALVERSA for the treatment of adults with mUC whose tumors have certain FGFR alterations. In 2008, Janssen entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialize BALVERSA. BALVERSA will be commercially available through the single-source specialty pharmacy provider US Bioservices.

For more information about BALVERSA, visit www.BALVERSA.com.

Indication

BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma which has

susceptible FGFR3 or FGFR2 genetic alterations and
progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA.

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.

BALVERSA (erdafitinib) Important Safety Information
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 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-two percent of patients received phosphate binders during treatment with BALVERSA Monitor for hyperphosphatemia and follow the dose modification guidelines when required [see Dosage and Administration 2.2, 2.3].

Embryo-fetal Toxicity – 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 prior to and during treatment, 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% were: phosphate increased(76%), stomatitis(56%), fatigue(54%), creatinine increased(52%), diarrhea(47%), dry mouth(45%), onycholysis(41%), alanine aminotransferase increased(41%), alkaline phosphatase increased(41%), sodium decreased(40%), decreased appetite(38%), albumin decreased(37%), dysgeusia(37%), hemoglobin decreased(35%), dry skin(34%), aspartate aminotransferase increased(30%), magnesium decreased(30%), dry eye(28%), alopecia(26%), palmar-plantar erythrodysesthesia syndrome(26%), constipation(28%), phosphate decreased(24%), abdominal pain(23%), calcium increased(22%), nausea(21%), and musculoskeletal pain(20%). The most common Grade 3 or greater ARs (>1%) were stomatitis(9%), nail dystrophy*, palmar-plantar erythrodysesthesia syndrome(6%), paronychia(3%), nail disorder*, keratitis^, onycholysis(10%*) and hyperphosphatemia.

*Included within onycholysis. ^Included within dry eye.

An adverse reaction with a fatal outcome in 1% of patients was acute myocardial infraction.

Serious adverse reactions occurred in 41% of patients including eye disorders (10%).

Permanent discontinuation due to an adverse reaction occurred in 13% of patients. The most frequent reasons for permanent discontinuation included eye disorders (6%).

Dosage interruptions occurred in 68% of patients. The most frequent adverse reactions requiring dosage interruption included hyperphosphatemia (24%), stomatitis (17%), eye disorders (17%) and palmar-plantar erythrodysaesthesia syndrome (8%).

Dose reductions occurred in 53% of patients. The most frequent adverse reactions for dose reductions included eye disorders (23%), stomatitis (15%), hyperphosphatemia (7%), palmar-plantar erythrodysaesthesia syndrome (7%), paronychia (7%) and nail dystrophy (6%).

Drug Interactions

Strong CYP2C9 or CYP3A4 Inhibitors – Consider alternative agents or monitor closely for adverse reactions. (7.1)
Strong CYP2C9 or CYP3A4 inducers: Avoid concomitant use with BALVERSA. (7.1)
Moderate CYP2C9 or CYP3A4 inducers: Increase BALVERSA dose up to 9 mg. (7.1)
Serum phosphate level-altering agents: Avoid concomitant use with agents that can alter serum phosphate levels before the initial dose modification period. (2.3, 7.1)
CYP3A4 substrates: Avoid concomitant use with sensitive CYP3A4 substrates with narrow therapeutic indices. (7.2)
OCT2 substrates: Consider alternative agents or consider reducing the dose of OCT2 substrates based on tolerability. (7.2)
P-gp substrates: Separate BALVERSA administration by at least 6 hours before or after administration of P-gp substrates with narrow therapeutic indices, (7.2)

QIAGEN Launches First FDA-Approved Companion Diagnostic Using FGFR Alterations to Help Guide the Treatment of Metastatic Urothelial Cancer

On April 12, 2019 QIAGEN N.V. (NYSE:QGEN; Frankfurt Prime Standard:QIA) reported the U.S. launch of its novel therascreen FGFR RGQ RT-PCR Kit (therascreen FGFR Kit) as a companion diagnostic to help guide the use of the newly approved FGFR kinase inhibitor, BALVERSA (erdafitinib), developed by Janssen Biotech, Inc. (Janssen) (Press release, Qiagen, APR 12, 2019, View Source [SID1234535118]). The test will aid in identifying patients with urothelial cancer whose tumors have certain alterations in the fibroblast growth factor receptor 3 (FGFR3) gene. The U.S. Food and Drug Administration co-approved the new test with BALVERSA, as announced today by Janssen.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Urothelial cancer begins in tissues lining the bladder and other genitourinary organs and is the sixth most common type of cancer in the United States. An estimated 15,000 patients a year in the United States are diagnosed with advanced or metastatic urothelial cancer, but current treatment options are limited so the prognosis is poor. A percentage of urothelial carcinoma tumors have certain FGFR alterations which are thought to be key drivers of tumor growth. Detection of these alterations utilizing the companion diagnostic will help identify patients eligible for treatment with BALVERSA. The therascreen FGFR Kit will run on QIAGEN’s Rotor-Gene Q MDx, a member of the modular QIAsymphony family of automation solutions and leverages a worldwide exclusive license for in-vitro diagnostic use of FGFR3:TACC3 fusions from Columbia University.

"We are very excited about the launch of the new therascreen FGFR Kit, the first companion diagnostic test to obtain FDA approval for detection of FGFR gene alterations to guide therapy in any cancer indication. Using our test to help guide treatment decisions in urothelial cancer will address a high unmet medical need among patients," said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. "The new therascreen FGFR Kit and significant testing capacities at leading laboratories will be available through QIAGEN’s Day-One Lab Readiness program to accelerate the availability of innovations in Precision Medicine."

An updated list of laboratories offering the new therascreen FGFR Kit under QIAGEN’s Day-One Lab Readiness program is available on QIAGEN’s FGFR lab finder web page (www.qiagen.com/fgfr-lab-finder).

QIAGEN is a pioneer in Precision Medicine and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making on the use of drugs in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from NGS to PCR for companion diagnostic development and is currently working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates. The therascreen FGFR Kit co-approval with BALVERSA marks the sixth FDA approval of a therapy with a QIAGEN companion diagnostic assay. For more information on QIAGEN’s companion diagnostics please visit www.qiagen.com.