Lung Metastases Imaging: Practice Essentials, Radiography, Computed Tomography
Risk Adjusted Net Present Value: What Is The Current Valuation Of Roche's Tiragolumab?
Page not found - Pharmaceutical TechnologySorry, we can't find the page you're looking for.
To get you back on track you can use the navigation at the top of the page, go back to the homepage or use the search below:
Search the website for what you looking for
Registration is disabled.
FDA'S ODAC To Discuss PD-L1 Levels For ICIs In Gastric And Esophageal Cancers
The FDA's Oncologic Drug Advisory Committee will meet on September 26, 2024, to discuss PD-L1 cutoffs for immune checkpoint inhibitors in gastric, gastroesophageal, and esophageal cancers.
Microscopic image of gastric tumor cells - Generated with Google Gemini AI
On September 26, 2024, the FDA's ODAC will convene to conduct risk-benefit assessments of PD-L1 expression level cutoffs for immune checkpoint inhibitor treatment for patients with gastric, gastroesophageal, and esophageal cancers.1
In the morning session, the Committee will discuss the use of immune checkpoint inhibitors in unresectable or metastatic gastric and GEJ cancers. The FDA is looking for the Committee's opinion on the adequacy of PD-L1 expression as a predictive biomarker, risks and benefits of PD-L1 expression analysis in different subgroups, and the adequacy of data to restrict the approval of immune checkpoint inhibitors based on PD-L1 expression. Here, the sBLAs of nivolumab and pembrolizumab and the BLA of tislelizumab for these indications will be discussed.
In the afternoon session, the Committee will consider immune checkpoint inhibitors in patients with metastatic or unresectable esophageal squamous cell carcinoma (ESCC), with the same considerations as the morning session. The Committee will discuss the sBLAs for pembrolizumab, nivolumab, and ipilimumab and the BLA for tislelizumab for this indication.
"With proven survival benefits, [nivolumab]-based regimens have changed the outlook for patients with [gastric cancer], GEJ [cancer], [esophageal adenocarcinoma] and ESCC regardless of PD-L1 status," Ian M. Waxman, MD, vice president, senior global program lead, late development, oncology, Bristol Myers Squibb, said in a press release.2 "We look forward to the opportunity to discuss the importance of [nivolumab]-based regimens as treatment options for appropriate gastric and esophageal cancer patients more in depth with the Committee."Bristol Myers Squibb is the sponsor of the sBLAs of nivolumab and ipilimumab.
During the meeting, the ODAC will hear from Bristol Myers Squibb, Merck, and BeiGene, sponsors of these sBLAs and BLAs.
Currently, the BLA of tislelizumab has a Prescription Drug User Fee Act target action date of December 1, 2024.3 Nivolumab, pembrolizumab, and ipilimumab are already approved for these indications.1
REFERENCES: 1. September 26, 2024: Meeting of the Oncologic Drugs Advisory Committee meeting announcement. FDA. August 23, 2024. Accessed August 26, 2024. Https://tinyurl.Com/mst9ffud 2. Bristol Myers Squibb statement on Oncologic Drugs Advisory Committee (ODAC) meeting to discuss PD-L1 expression levels in gastric and esophageal cancers. News release. Bristol Myers Squibb. August 22, 2024. Accessed August 26, 2024. Https://tinyurl.Com/2va7jb97 3. BeiGene's biologics license application for TEVIMBRA® (tislelizumab) for first-line gastric or gastroesophageal junction cancers accepted by FDA. News release. BeiGene, Ltd. February 27, 2024. Accessed August 26, 2024. Https://tinyurl.Com/2bfxky4jRisk Adjusted Net Present Value: What Is The Current Valuation Of Roche's Tobemstomig?
The revenue for Tobemstomig is expected to reach an annual total of $70 mn by 2040 in the US based off GlobalData's Expiry Model. The drug's revenue forecasts along with estimated costs are used to measure the value of an investment opportunity in that drug, otherwise known as net present value (NPV). Applying the drug's phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV). The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress.
Tobemstomig OverviewRG-6139 (RO-7247669) is under development for the treatment of metastatic solid tumors including metastatic melanoma, triple-negative breast cancer (TNBC), advanced or metastatic renal cell carcinoma, non-small cell lung cancer, metastatic urothelial cancer, ureter cancer, bladder cancer, urethra cancer and esophageal squamous cell carcinoma. It is administered via intravenous route. The therapeutic candidate is a bi-specific monoclonal antibody which acts by targeting programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 protein (LAG3).
Roche OverviewRoche is a holding company that is involved in the business of offering oncology, immunology, infectious diseases, ophthalmology and neuroscience research services. The company is headquartered in Basel, Basel-Stadt, Switzerland.The company reported revenues of (Swiss Francs) CHF58,716 million for the fiscal year ended December 2023 (FY2023), a decrease of 7.2% over FY2022. In FY2023, the company's operating margin was 25.8%, compared to an operating margin of 27.5% in FY2022. In FY2023, the company recorded a net margin of 19.6%, compared to a net margin of 19.6% in FY2022.
For a complete picture of Tobemstomig's valuation, buy the drug's risk-adjusted NPV model (rNPV) here.
From 
Blending expert knowledge with cutting-edge technology, GlobalData's unrivalled proprietary data will enable you to decode what's happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.
Be better informed
GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, drug margins and company expenses. Combining these data points with GlobalData's world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.
The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate valuation, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData's rNPV model uses proprietary likelihood of approval (LoA) and phase transition success rate (PTSR) data for the indication in the highest development stage, which can be found on GlobalData's Pharmaceutical Intelligence Center.
Comments
Post a Comment