On June 7, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported positive results from a Phase 2/3 trial, developed and conducted in close collaboration with the Children’s Oncology Group (COG), evaluating the intramuscular (IM) administration of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) in adult and pediatric patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who have developed hypersensitivity to an E. coli-derived asparaginase (Press release, Jazz Pharmaceuticals, JUN 7, 2022, View Source [SID1234615734]). These results will be presented as an oral presentation today at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting.

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These results confirm the interim trial analysis presented in December 2021 at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, and demonstrated that ≥90% of patients in Cohort 1c receiving the IM dosing regimen of 25/25/50 mg/m2 administered Monday/Wednesday/Friday (MWF) achieved nadir serum asparaginase activity (NSAA) levels ≥0.1 IU/mL at 48 and 72 hours, with a safety profile consistent with what has been described for other asparaginases.

"We are excited to share these results from the Phase 2/3 trial of Rylaze highlighting the clinically meaningful nadir serum asparaginase activity from the Monday/Wednesday/Friday dosing regimen, which supports a new dosing schedule that aligns with current clinical practice," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "Rylaze is an example of how Jazz and the Children’s Oncology Group have advanced a critically needed treatment from development through FDA approval, and then continue to explore additional dosing and administration options to address the needs of patients."

"Asparaginase-based therapies remain a cornerstone in ALL and LBL treatment, and Rylaze has been an important option for patients who develop a hypersensitivity to an E. coli-derived asparaginase since its approval last year," said trial primary investigator Dr. Luke Maese, associate professor of pediatric hematology-oncology at the University of Utah, Primary Children’s Hospital and Huntsman Cancer Institute. "It’s encouraging to see these data further support an IM Monday/Wednesday/Friday dosing schedule for Rylaze, which is more in line with clinical practice in the U.S., in addition to the currently approved schedule of every 48 hours."

Rylaze was approved in the U.S. in 2021 for use as a component of a multi-agent chemotherapeutic regimen for the treatment of ALL and LBL in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase. It was approved with an IM dosing schedule of 25 mg/m2 every 48 hours based on observed data from the Phase 2/3 trial, in conjunction with data produced by a population pharmacokinetic (PPK) model. Data from the Phase 2/3 trial supported additional regulatory filings for Rylaze, including two supplemental Biologics Licensing Applications (sBLA) to the U.S. FDA to support MWF IM dosing completed in January 2022 and IV administration options completed in April 2022.

Trial Results
Data presented at ASCO (Free ASCO Whitepaper) include efficacy and safety results from the Phase 2/3 open-label, multicenter, pharmacokenitic (PK) trial of Rylaze (also known as JZP458) in patients with ALL/LBL who developed hypersensitivity or silent inactivation to a long-acting E. coli-derived asparaginase. These results are from Part A of the trial, which investigated three cohorts via IM administration:

Cohort 1a (n=33): studied a dose of 25 mg/m2 Monday/Wednesday/Friday
Cohort 1b (n=83): studied a dose of 37.5 mg/m2 Monday/Wednesday/Friday
Cohort 1c (n=51): studied a dose of 25 mg/m2 on Monday and Wednesday and 50 mg/m2 on Friday
Efficacy Findings
The primary efficacy endpoint of the trial was the proportion of patients with NSAA levels ≥0.1 IU/mL at the last 72-hours during the first treatment course.

The key secondary endpoint was the proportion of patients with NSAA levels ≥0.1 IU/mL at the last 48-hours during the first treatment course.

A population PK (PPK) model was developed based on SAA data from the clinical trial to characterize the PK of JZP458 when given IM and to inform dosing decisions. Simulated data from the PPK model matched the observed data well.

Based on a PPK modeling and simulation analysis, the proportion of patients predicted to achieve NSAA levels ≥0.1 IU/mL with a 95% CI in Cohort 1c at the last 72- and 48-hour in Course 1 were 92% (91%, 93%) and 94% (93%, 95%) respectively, based on modeled data.

Safety Findings
In Cohort 1c in this trial, the following treatment-related adverse events (TRAEs) leading to discontinuation were observed:

Patients, n (%)

Cohort 1c:

25/25/50 mg/m2 MWF

(n = 51)

Any TRAE leading to study drug discontinuation

5 (10)

Pancreatitis

4 (8)

Drug hypersensitivity

1 (2)

Anaphylactic reaction

0

Increased ALT

0

Hyperammonemia

0

There were no TRAEs leading to death.

The safety profile of JZP458 is consistent with the published literature on asparaginase given as a component of a multiagent chemotherapeutic regimen.1,2,3,4,5

About Rylaze ( asparaginase erwinia chrysanthemi (recombinant)-rywn)
Rylaze, also known as JZP458, is approved in the U.S. for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase. Rylaze has orphan drug designation for the treatment of ALL/LBL in the United States. Rylaze is a recombinant erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. JZP458 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in October 2019 for the treatment of this patient population. Rylaze was approved as part of the Real-Time Oncology Review (RTOR) program, an initiative of the FDA’s Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients.

The full U.S. Prescribing Information for Rylaze is available at: <View Source>

Important Safety Information

RYLAZE should not be given to people who have had:

Serious allergic reactions to RYLAZE
Serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment
RYLAZE may cause serious side effects, including:

Allergic reactions (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, or trouble breathing), some of which may be life-threatening
Swelling of the pancreas (stomach pain)
Blood clots (may have a headache or pain in leg, arm, or chest)
Bleeding
Liver problems
Contact your doctor immediately if any of these side effects occur.

Some of the most common side effects with RYLAZE include: liver problems, nausea, bone and muscle pain, tiredness, infection, headache, fever, allergic reactions, fever with low white blood cell count, decreased appetite, mouth swelling (sometimes with sores), bleeding, and too much sugar in the blood.

RYLAZE can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving RYLAZE and for 1 week after the final dose.

Tell your healthcare provider if there are any side effects that are bothersome or that do not go away.

These are not all the possible side effects of RYLAZE. For more information, ask your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

About Acute Lymphoblastic Leukemia (ALL)
ALL is a cancer of the blood and bone marrow that can progress quickly if not treated.6 Leukemia is the most common cancer in children, and about three out of four of these cases are ALL.7 Although it is one of the most common cancers in children, ALL is among the most curable of the pediatric malignancies due to recent advancements in treatment.8,9 Adults can also develop ALL, and about four of every 10 cases of ALL diagnosed are in adults.10 The American Cancer Society estimates that about 6,600 new cases of ALL will be diagnosed in the United States in 2022.10 Asparaginase is a core component of multi-agent chemotherapeutic regimens in ALL.11 However, asparaginase treatments derived from E. coli are associated with the potential for development of hypersensitivity reactions.1

About Lymphoblastic Lymphoma (LBL)
LBL is a rare, fast-growing, aggressive subtype of Non-Hodgkin’s lymphoma, most often seen in teenagers and young adults.6 LBL is a very aggressive lymphoma – also called high-grade lymphoma – which means the lymphoma grows quickly with early spread to different parts of the body.12,13

On June 7, 2022 Amyris, Inc. (Nasdaq: AMRS), a leading synthetic biotechnology company accelerating the world’s transition to sustainable consumption through its Lab-to-Market technology platform, reported that management will participate in a virtual fireside chat at the Oppenheimer 22nd Annual Consumer Conference on Tuesday, June 14, 2022, at 11:15 am ET (Press release, Amyris Biotechnologies, JUN 7, 2022, View Source [SID1234615733]).

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A live webcast of the presentation and a replay will be available on the Investor Relations section of the company’s website at View Source

On June 7, 2022 Ichnos Sciences Inc., a clinical-stage global biotechnology company developing innovative multispecific antibodies for oncology, reported that its president and chief executive officer, Cyril Konto, M.D., will present at the 2022 Jefferies Healthcare Conference in New York on Wednesday, June 8 at 3:30 PM Eastern Time (Press release, Ichnos Sciences, JUN 7, 2022, View Source [SID1234615732]).

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"Ichnos has been working to develop and advance therapies for cancer that extend and improve survival and quality of life, driven by the belief that cure is possible," said Cyril Konto, M.D., President and Chief Executive Officer of Ichnos Sciences. "We are excited to come together with other health and biotech innovators at the Jefferies Conference and honored to have the opportunity to share our plans for shifting medicine forward."

Dr. Konto’s presentation comes just weeks after Ichnos announced the selection of its ISB 2001 TREAT1 trispecific antibody, the first T cell-engaging antibody that targets BCMA and CD38 on multiple myeloma cells, as its next candidate to move into clinical development. Ichnos’ pipeline also includes ISB 1342, a CD38 x CD3 bispecific antibody, which continues to enroll patients with relapsed/refractory multiple myeloma in an ongoing Phase 1, dose escalation and expansion study, and ISB 1442, a CD38 x CD47 biparatopic bispecific antibody for which a Phase 1 study in relapsed/refractory multiple myeloma is planned to start shortly.

A live webcast of the presentation can be accessed through this link. A replay of the webcast will be available for one year following the conference.

On June 7, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported initial results from the pivotal Phase 2 RAGNAR study evaluating the investigational use of BALVERSA (erdafitinib), a fibroblast growth factor receptor (FGFR) kinase inhibitor, in patients with advanced solid tumors with prespecified FGFR alterations (Press release, Johnson & Johnson, JUN 7, 2022, View Source [SID1234615731]). At a planned interim analysis (IA), responses were observed across a variety of FGFR-driven solid tumors for patients who had exhausted standard treatment options prior to being treated with BALVERSA.1 These results will be featured in an oral presentation (Abstract #3007) today at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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RAGNAR (NCT04083976) is a Phase 2 clinical study designed to evaluate the efficacy and safety of BALVERSA in patients with advanced or metastatic solid tumors and prespecified FGFR gene alterations, regardless of tumor location or histology (tumor-agnostic). The IA was based on 178 patients with 32 distinct solid tumor histologies.1 Patients in the study were prospectively identified by local molecular testing or central next-generation sequencing (NGS); the most common tumor types were cholangiocarcinoma (bile duct cancer) (n=31), high-grade glioma (tumor of the brain or spinal cord) (n=29), breast cancer (n=14), pancreatic cancer (n=13) and squamous non-small cell lung cancer (n=11).1 The study also included tumors that occur less frequently in the real world such as salivary gland and parathyroid carcinomas (rare endocrine malignancies), as well as tumors of unknown primary origin.1 Study participants were heavily pretreated, with 74.7 percent (n=133) having received two or more prior lines of therapy.1

The primary endpoint of the RAGNAR study is the overall response rate (ORR) as assessed by an independent review committee (IRC). At the IA data cutoff, IRC assessed an ORR of 29.2 percent (95 percent confidence interval [CI], 22.7-36.5) and a disease control rate (DCR) of 72.5 percent (95 percent CI, 65.3-78.9) for the overall tumor-agnostic patient population.1 Investigators observed responses in 14 distinct tumor types. This included responses in hard-to-treat malignancies such as salivary gland cancer (100 percent ORR; treated n=5, responders n=5), pancreatic cancer (31 percent ORR; treated n=13, responders n=4) and glioblastoma (21 percent ORR; treated n=29, responders=6).1 Investigators also observed an overall 7.1-month median duration of response (DOR) (95 percent CI, 5.5-9.3)1. At the data cutoff, 51.1 percent (n=24) of patients who had responded to treatment continued to show a response.1 The primary analysis for all patients treated in this RAGNAR cohort, known as the broad panel cohort, is anticipated later this year.

The safety profile of BALVERSA observed in RAGNAR was consistent with the known safety profile of BALVERSA in metastatic urothelial carcinoma (mUC). Across tumor types, 44.9 percent of patients experienced adverse events of grade three or above.1 Adverse events were manageable with supportive care and treatment interruptions or reductions, when necessary.1 The discontinuation rate due to drug-related adverse events was 7.3 percent.1

"Diagnostic advances in the identification of FGFR gene alterations have opened the door to targeted, tumor-agnostic treatment approaches for patients," said Yohann Loriot, M.D., Ph.D., Institut Gustave Roussy and University of Paris-Saclay, and principal study investigator.‡ "Results from the RAGNAR study show that, through the targeted inhibition of FGFR receptors, we may be able to tailor treatment for patients with advanced FGFR-driven cancers, regardless of tumor location or histology."

In 2019, BALVERSA was granted accelerated approval by the U.S. Food and Drug Administration (FDA) as a targeted therapy for adult patients with locally advanced or mUC with susceptible FGFR2 or FGFR3 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.2

"Janssen is committed to advancing precision medicine approaches for the treatment of patients with biomarker-driven cancers, an area of clear unmet need," said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. "RAGNAR, Janssen’s first tumor-agnostic study, demonstrates our commitment to understand the biology of disease, identify new treatment pathways and improve patient outcomes. We look forward to progressing the development of BALVERSA for these patients and sharing additional updates on this program in the future."

About FGFR Alterations
Fibroblast growth factor receptors are a family of receptor tyrosine kinases that help cells grow, survive and multiply; FGFRs play a key role in several biological processes including tissue repair, inflammatory response and metabolism.3,4,5 Fusions or mutations in the genes that control FGFR (known as FGFR1–4 alterations) may lead to the development and progression of certain cancers by increasing tumor cell growth and survival.4 Patients with advanced, FGFR-driven solid tumors who have exhausted standard treatment options typically face a poor prognosis.

About the RAGNAR Study
RAGNAR (NCT04083976) is a Phase 2 clinical trial evaluating the safety and efficacy of BALVERSA in patients with advanced solid tumors, regardless of cancer type or tumor location (tumor-agnostic), driven by FGFR1–4 alterations. Patients in the trial have progressed on or after at least one line of systemic therapy and have no alternative standard treatment options. Following screening by local molecular testing or central NGS, patients are enrolled in four separate cohorts: a broad panel cohort of patients with pathogenic FGFR mutations or gene fusions (tumor histologies evaluated include but are not limited to cholangiocarcinoma [bile duct cancer], high- and low-grade glioma [a tumor type occurring in the brain or spinal cord], breast, pancreatic, squamous and non-squamous non-small cell lung cancer, colorectal, endometrial, esophageal, salivary gland, ovarian, duodenal [cancer occurring in the first part of the small intestine], thyroid and cancer of unknown primary origin); an exploratory cohort of patients with other FGFR mutations; a cholangiocarcinoma expansion cohort; and a pediatric cohort of patients ages 6 to 17 with FGFR alterations.1

The primary endpoint of RAGNAR is IRC-assessed ORR. Key secondary endpoints include investigator-assessed ORR, DOR, DCR, clinical benefit rate, progression free survival, overall survival and incidence and severity of adverse events.

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 has susceptible FGFR3 or FGFR2 genetic alterations and has 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: View Source 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.2,6

In addition to RAGNAR, BALVERSA is being studied in clinical trials including the Phase 3 THOR (NCT03390504) study evaluating BALVERSA versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations with disease progression following one or two prior lines of therapy; and the randomized Phase 2 THOR-2 (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.7,8

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.

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-uremic calciphylaxis 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-two percent of patients received phosphate binders during treatment with BALVERSA. Cutaneous calcinosis, non-uremic calciphylaxis 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-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 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%:
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 adverse reactions (>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 infarction.
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 erythrodysesthesia 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 erythrodysesthesia syndrome (7%), paronychia (7%), and nail dystrophy (6%).
Drug Interactions

Moderate CYP2C9 or strong 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)
Use in Specific Populations
Lactation – Because of the potential for serious adverse reactions from erdafitinib in a breastfed child, advise lactating women not to breastfeed during treatment with BALVERSA and for one month following the last dose.

Please see the full Prescribing Information for BALVERSA.

On June 7, 2022 Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, reported that compelling results in 926 women diagnosed with ductal carcinoma in situ (DCIS) (Press release, Prelude Therapeutics, JUN 7, 2022, View Source [SID1234615730]). The new information was presented in an oral abstract session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting at McCormick Place, Chicago, IL.

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The results of the study demonstrated that after breast conserving surgery (BCS) patients in the DCISionRT elevated risk group had a significant risk reduction from endocrine therapy (ET), while those patients in the DS low risk group did not have a significant risk reduction from ET.

"For the first time, physicians have access to an enhanced method of identifying which patients may have a significant or minimal benefit from adjuvant endocrine therapy based on individual tumor biology," said Pat Whitworth, MD, FACS, ASCO (Free ASCO Whitepaper) Presenter and Breast Surgical Oncologist Director, Nashville Breast Center; Associate Professor, University of Tennessee; and Managing Partner TME. "The results are meaningful and support a more tailored treatment plan for our DCIS patients."

DCISionRT stratified patients as low risk, neither adjuvant ET nor radiation therapy (RT) resulted in reduced 10-year ipsilateral breast recurrence (IBR) (5.6% BCS+ET vs BCS alone). Patients in the elevated risk group, benefited from adjuvant ET as well as RT.

"We are excited to share this unique data demonstrating the expanded utility of DCISionRT to guide personalized treatment decisions for DCIS patients," says Dan Forche, President and CEO of PreludeDx. "As precision medicine becomes the new standard of care, we are committed to continuous innovation to improve healthcare outcomes for early-stage breast cancer patients, clinicians and the healthcare system."

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.