SCHEDULE A CALL
RxTROSPECT Vid 169 (1).gif

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
SEAGEN's Tivdak confirms benefit in recurrent or metastatic cervical cancer with disease progression on or after chemotherapy; AA PMR fulfilled

SEAGEN's Tivdak confirms benefit in recurrent or metastatic cervical cancer with disease progression on or after chemotherapy; AA PMR fulfilled

  • Efficacy was evaluated in innovaTV 301 (NCT04697628), an open-label, active-controlled, multicenter, randomized trial that enrolled 502 patients with recurrent or metastatic cervical cancer who had received one or two prior systemic regimens, including chemotherapy with or without bevacizumab and/or an anti-PD-(L)-1 agent

  • Median OS was 11.5 months (95% CI: 9.8, 14.9) vs. 9.5 months (95% CI: 7.9, 10.7) in the chemotherapy arm (HR 0.70 [95% CI: 0.54, 0.89] p-value 0.0038)

  • Trial’s results fulfill the post-marketing requirement of the FDA's 2021 accelerated approval for this indication

Read More →
Another First as FDA grant accelerated approval to tovorafenib for patients with r/r BRAF-altered pediatric low-grade glioma

Another First as FDA grant accelerated approval to tovorafenib for patients with r/r BRAF-altered pediatric low-grade glioma

  • First FDA approval of a systemic therapy for the treatment of patients with pediatric LGG with BRAF rearrangements, including fusions

  • Efficacy was evaluated in 76 patients enrolled in FIREFLY-1 (NCT04775485), a multicenter, open-label, single-arm trial

  • ORR was 51% (95% CI: 40, 63) and median DoR was 13.8 months (95% CI: 11.3, not estimable)

Read More →
First FDA approval of a radiopharmaceutical for pediatric patients 12+ with SSTR-positive GEP-NETs

First FDA approval of a radiopharmaceutical for pediatric patients 12+  with SSTR-positive GEP-NETs

  • Lutathera (lutetium Lu 177 dotatate) 2018 adult indication expanded to pediatrics 12 years+ with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

  • Approval was based on PK, dosimetry, and safety data from NETTER-P (NCT04711135), an ongoing, open-label, single-arm study in adolescent patients with locally advanced/inoperable or metastatic SSTR-positive GEP-NETs or pheochromocytoma/paraganglioma (PPGL).

  • Approval was also based on the extrapolation of efficacy outcomes observed in NETTER-1 (NCT01578239), which supported the original approval in adults.

  • NETTER-P was conducted as part of a pediatric Written Request (WR) under the Best Pharmaceuticals for Children Act (BPCA).

Read More →
FDA approves Altor BioScience's Anktiva (nogapendekin alfa inbakicept) for BCG-unresponsive non-muscle invasive bladder cancer

FDA approves Altor BioScience's Anktiva (nogapendekin alfa inbakicept) for BCG-unresponsive non-muscle invasive bladder cancer

  • Efficacy was evaluated in QUILT-3.032 (NCT0302285), a single-arm, multicenter trial of 77 patients with BCG-unresponsive, high-risk NMIBC with CIS with or without Ta/T1 papillary disease following transurethral resection.

  • CR was defined by a negative cystoscopy (with TURBT/biopsies as applicable) and urine cytology. CR rate was 62% (95% CI: 51, 73). Fifty-eight percent of patients with CR had a DOR ≥ 12 months and 40% had a DOR ≥ 24 months.

  • The most common adverse reactions (≥15%), including laboratory test abnormalities, were increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.

Read More →
FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer

FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer

  • Phase III ALINA study showed alectinib reduced the risk of disease recurrence or death by 76% (HR=0.24, 95% CI: 0.13-0.43, p<0.0001) vs. platinum-based chemotherapy in people with completely resected IB (tumor ≥ 4 cm) to IIIA ALK-positive NSCLC.

  • In an exploratory analysis, an improvement of central nervous system (CNS)-DFS was observed (HR=0.22; 95% CI: 0.08-0.58).

  • Review utilized RTOR and Project Orbis (FDA w/Australia’s TGA, Health Canada, Israel’s MoH, Swissmedic & the UK’s MHRA). Brazil's ANVISA and Singapore’s HAS will also be participating as Type C Project Orbis Partners.

Read More →
CARVYKTI Becomes First and Only BCMA-Targeted Treatment Approved by the U.S. FDA in Second-line Multiple Myeloma

CARVYKTI Becomes First and Only BCMA-Targeted Treatment Approved by the U.S. FDA in Second-line Multiple Myeloma

  • Phase 3 CARTITUDE-4 study demonstrated earlier use of CARVYKTI® reduced the risk of disease progression or death by 59% vs. standard therapies—pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.

  • CARVYKTI received FDA approval in 2022 for more heavily pre-treated MM; this expansion of indication (unanimously supported by ODAC 11 to 0) moving the product into second-line MM.

  • In Europe, in February 2024 EMA's CHMP issued a positive opinion to move the therapy to second-line MM. EU approval is expected any day now.

Read More →
Desk Pic B&W.jpeg
 

WORK SMARTER, NOT HARDER