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ACCELERATING INNOVATION

 
 

FOR ONCOLOGY STRATEGY PROFESSIONALS

✔  First class analytics on oncology product approvals

✔  Rapidly identify regulatory precedent across US & EU

✔  Easily accessible & scalable across your organization

use case videos

RxTROSPECT allows you to identify approved, breakthrough therapy-designated, indications in seconds. Select the breakthrough filter and watch the RxTROSPECT dashboard update immediately. Interact with the charts, view details or navigate the top tabs to gain insights on everything from study design to study outcomes.

See which countries have been reviewing products from a rapporteur perspective. We'll also be looking at the approval details tabs to see the brand name of the product, the condition for which it's approved on, and all the primary endpoints. This is particularly helpful when planning your national scientific advice or at the time of your MAA.

RxTROSPECT allows you to identify products or groups of products based on the approved condition (e.g. NSCLC) and identify the phase of the registration study (e.g. Phase I, II or III). View a comprehensive summary of the benefit-risk profile for each approval at the time of the regulatory decision.

ON-DEMAND ANALYSIS

Whether you're at the tactical level doing regulatory research, or at the leadership level running regulatory strategy, we at RxTROSPECT understand how important it is for your team to make consistent and well-informed decisions. Your authorized access to our online tool empowers you to drive better decision-making across your entire organization. With a single source of clean objective data, RxTROSPECT enables regulatory experts to perform in-depth and objective inquiry into hundreds of oncology indications.

Never again will you need to worry about going through the rigmarole of data collection, then data validation, and finally preparing all of it in a report to get ready for an upcoming meeting. What previously would take days or weeks to collate using primitive research methods and time-consuming groundwork, with RxTROSPECT now only takes seconds. Go to work with the comfort of knowing that you are part of a team that actively seeks new and innovative technology to help their company work smarter, not harder.

RxTROSPECT FDA Approvals Oncology Analytics

IDENTIFY
PRECEDENT

Avoid the expense of collecting historical information on regulatory approvals and have confidence with years of reporting on-demand.

RxTROSPECT FDA Approvals Oncology Analytics

UNDERSTAND APPROVALS

Work smarter not harder, with our 'best-in-class' software letting you login and access information from your desktop, tablet or phone.

RxTROSPECT FDA Approvals Oncology Analytics

DE-RISK
STRATEGY

Review the outcome of past decisions with analysis that gives specific insight into precedent, based on prior regulatory approvals.

 
 

product UPDATE

From our Product Leadership

We are thrilled to share the release of our RxTROSPECT Oncology Europe module! This module has a similar look and feel to the US module and is a look-back at all centralized EU oncology approvals from the year 2000 to the present day.

Interact with these dashboards to rapidly identify precedent and trends on clinical trial design, benefit-risk, rapporteur countries, indications, regulatory designations and more. As one would expect, all key functionality remains to download summary data and to export into PowerPoint or Excel.

Our new EU module can be found published alongside the existing US FDA modules. Please do reach out to us (theteam@rxtrospect.com) or your designated company super-user with any questions or feedback.

RxTROSPECT have partnered with Tableau, a pioneer and leader in delivering business intelligence solutions.

This partnership with Tableau allows RxTROSPECT customers to receive a comprehensive end-to-end solution that lets them easily navigate information from a wide variety of data sources within one online platform — delivering a single version of truth.  By using RxTROSPECT as the solid foundation for analytics, you bring your company a scalable, structured and secure product that lies within a reliable self-service analytics framework, allowing you to practice near real-time analysis on large sets of data.

  • ➤ Easily access a single source of clean information to support better decision-making

    ➤ Create new reports and visualizations without waiting for IT to add data sources

    ➤ Add consistency to reports and presentations created through a secure and reliable platform

    ➤ Reduce external consultancy costs and reliance on in-house IT 

    ➤ Enhance scalability, with a single online solution rolled out enterprise-wide

    ➤ Avoid reporting errors due to changes in data sources or individual assumptions

latest APPROVALS & PRESS RELEASES

Featured
FDA accelerated approval for zanidatamab in previously treated, unresectable or metastatic HER2-positive (IHC 3+) Biliary Tract Cancer

FDA accelerated approval for zanidatamab in previously treated, unresectable or metastatic HER2-positive (IHC 3+) Biliary Tract Cancer

  • Jazz Pharmaceuticals announced FDA accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.

  • Ziihera was approved under accelerated approval based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months as determined by independent central review (ICR). The safety profile for Ziihera has been demonstrated in 80 patients in the HERIZON-BTC-01 trial.

  • The confirmatory, global, randomized Phase 3 trial HERIZON-BTC-302 (NCT06282575) is ongoing and is evaluating zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.

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AbbVie Receives European Approval of ELAHERE® (mirvetuximab soravtansine) for the Treatment of Platinum-Resistant Ovarian Cancer

AbbVie Receives European Approval of ELAHERE® (mirvetuximab soravtansine) for the Treatment of Platinum-Resistant Ovarian Cancer

  • ELAHERE is the first and only folate receptor alpha (FRɑ)-directed ADC approved in the Europe; supported by data from MIRASOL: a global, Phase 3 open-label, randomized, controlled trial.

  • Results presented at the 2023 ASCO  demonstrated a 35% reduction in the risk of tumor progression or death in patients treated in the ELAHERE arm compared with the investigator's choice (IC) chemotherapy arm, which represented an improvement in PFS [HR 0.65 (95% CI: 0.52, 0.81; p<0.0001)].

  • ELAHERE also demonstrated improvement in OS compared with IC chemotherapy, representing a 33% reduction in the risk of death in the ELAHERE arm in comparison to the IC chemotherapy arm [HR 0.67 (95% CI: 0.50, 0.89; p=0.0046)].

  • The most common adverse reactions with ELAHERE were blurred vision, nausea, diarrhea, fatigue, abdominal pain, keratopathy, dry eye, constipation, vomiting, decreased appetite, peripheral neuropathy, headache, asthenia, increased aspartate aminotransferase and arthralgia. The most commonly reported serious adverse reaction was pneumonitis.

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FDA approves revumenib for relapsed or refractory acute leukemia with a KMT2A translocation

FDA approves revumenib for relapsed or refractory acute leukemia with a KMT2A translocation

  • Efficacy was evaluated in a single-arm cohort of an open-label, multicenter trial (NCT04065399) in 104 adult and pediatric patients (at least 30 days old) with R/R acute leukemia with a KMT2A translocation.

  • CR+CRh rate was 21.2% (95% CI: 13.8, 30.3), and the median CR+CRh duration was 6.4 months (95% CI: 2.7, not estimable).

  • Among the 83 patients dependent on RBC and/or platelet transfusions at baseline, 12 (14%) became independent of RBC and platelet transfusions during any 56-day post-baseline period. Of the 21 patients independent of both RBC and platelet transfusions at baseline, 10 (48%) remained transfusion independent during any 56-day post-baseline period.

  • Due to an anticipated delay in commercial availability of the lowest dose strength of revumenib, which may be used to treat patients who weigh < 40 kg, revumenib will be available through an expanded access program to allow for dosing of patients who weigh < 40 kg (information available here: NCT05918913).

  • This review used RTOR pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid. FDA approved this application 6 weeks early.

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FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia

FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia

  • Efficacy was evaluated in FELIX (NCT04404660), an open-label, multicenter, single-arm trial that enrolled adults with relapsed or refractory CD19-positive B-cell ALL.

  • Of the 65 patients evaluable for efficacy, 27 patients (42%; 95% CI: 29%, 54%) achieved CR within 3 months. Median duration of CR achieved within 3 months was 14.1 months (95% CI: 6.1, not reached).  Label has a boxed warning for CRS, ICANS and T cell malignancies.

  • Product granted regenerative medicine advanced therapy designation and orphan drug designation. This is the first FDA approval for Autolus Therapeutics.

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FDA grant accelerated approval to asciminib (Scemblix, Novartis AG) for adult patients with newly diagnosed Ph+ CML)in chronic phase

FDA grant accelerated approval to asciminib (Scemblix, Novartis AG) for adult patients with newly diagnosed Ph+ CML)in chronic phase

  • The efficacy of asciminib for newly diagnosed Ph+ CML in CP was evaluated in ASC4FIRST (NCT04971226), a multicenter, randomized, active-controlled, open-label trial. A total of 405 patients were randomized (1:1) to receive either asciminib or investigator-selected tyrosine kinase inhibitors (IS-TKIs) (imatinib, nilotinib, dasatinib, or bosutinib).

  • The MMR rate at 48 weeks was 68% (95% CI: 61, 74) in the asciminib arm and 49% (95% CI: 42, 56) in the IS-TKIs arm (difference 19% [95% CI: 10, 28], p-value <0.001).

  • Within the imatinib stratum, the MMR rate was 69% (95% CI: 59, 78) in the asciminib arm and 40% (95% CI: 31, 50) in the IS-TKIs arm (difference 30% [95% CI: 17, 42], p-value <0.001).

  • Project Orbis included Health Canada and Switzerland’s Swissmedic (SMC). The application reviews are ongoing at the other regulatory agencies.

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FDA approves Astellas’ Vyloy for first-line gastric or gastroesophageal junction adenocarcinoma

FDA approves Astellas’ Vyloy for first-line gastric or gastroesophageal junction adenocarcinoma

  • In GLOW, 507 patients were randomized to receive either zolbetuximab with CAPOX chemotherapy or placebo with CAPOX chemotherapy: Median PFS was 8.2 months vs. 6.8 months in the placebo, hazard ratio 0.75; Median OS was 18.2 months vs. and 15.5 months respectively, HR 0.75 in favor.

  • In SPOTLIGHT, 565 patients were randomized to receive zolbetuximab with mFOLFOX6 chemotherapy or placebo with mFOLFOX6 chemotherapy. Median PFS was 10.6 months vs. 8.7 months in the placebo/chemotherapy arm. Median OS was 18.2 months and 15.5 months respectively, HR 0.75

  • The most common serious adverse reactions in SPOTLIGHT (≥2%) were vomiting, nausea, neutropenia, febrile neutropenia, diarrhea, intestinal obstruction, pyrexia, pneumonia, respiratory failure, pulmonary embolism, decreased appetite, and sepsis.

Read More →
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WORK SMARTER, NOT HARDER