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RVMD Secures FDA Win, Gets Nod for Rasonque in Pancreatic Cancer
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Key Takeaways
Revolution Medicines won FDA approval for Rasonque in previously treated metastatic pancreatic cancer.
Rasonque cut death risk 60% versus chemotherapy and nearly doubled median overall survival.
Once-daily oral dosing and better quality-of-life results could make the drug an alternative to chemotherapy.
Revolution Medicines (RVMD - Free Report) announced that the FDA has approved its RAS inhibitor daraxonrasib for previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The drug will be marketed under the brand name Rasonque.
Why the Approval Is a Big Deal for RVMD
The approval marks a major inflection point for Revolution Medicines, making Rasonque the company’s first marketed product and transforming it from a clinical-stage biotech into a commercial-stage oncology company.
The FDA’s decision is supported by data from the phase III RASolute 302 study, which met all its primary and secondary endpoints. Recently, Revolution Medicines reported full results from this study, which showed that daraxonrasib reduced the risk of death by 60% compared with cytotoxic chemotherapy and nearly doubled median overall survival. The treatment also significantly improved progression-free survival and quality-of-life measures.
Beyond its efficacy, however, Rasonque could have another important advantage over chemotherapy — greater convenience of administration. The drug is available as a once-daily oral tablet, whereas the chemotherapy regimens used in RASolute 302 required intravenous administration.
As a result, Rasonque could challenge cytotoxic chemotherapy as a preferred treatment option in previously treated metastatic PDAC, an area with limited treatment options. Its combination of once-daily oral administration, improved clinical outcomes and favorable patient-reported quality-of-life results could make it an attractive alternative to conventional chemotherapy in this setting.
The approval comes a month after the FDA accepted the regulatory submission for the drug. The agency reviewed the filing under the Commissioner’s National Priority Voucher pilot program, which is designed to accelerate the review process and targets a review timeline of one to two months.
RVMD Stock’s Price Performance
Despite the positive announcement, investor reaction to the stock remained muted yesterday. This was likely due to the wholesale acquisition cost of $39,800 set by the company for a 30-day supply of the drug, which was higher than what investors had initially been expecting.
Year to date, the company’s shares have skyrocketed 177% compared with the industry’s 12% growth.
Image Source: Zacks Investment Research
FDA Approval Validates RVMD’s RAS Pipeline
The approval also strengthens Revolution Medicines’ position in RAS-driven cancers and provides a commercial foundation for advancing its broader oncology pipeline. Rasonque is designed to target a broad spectrum of RAS-driven cancers, including PDAC, non-small cell lung cancer (NSCLC) and colorectal cancer.
Beyond the currently approved indication, Revolution Medicines is evaluating the drug inseveral other PDAC settings in late-stage studies. While the RASolute 303 study is assessing the drug for the first-line metastatic setting of the disease, the RASolute 304 study is evaluating its efficacy as an adjuvant therapy for patients with resectable PDAC.
The company is also conducting the phase III RASolve 301 study, which is evaluating Rasonque in patients with locally advanced or metastatic RAS-mutated NSCLC. Initial data from this study are expected next year.
Revolution Medicines is also developing mutant-selective inhibitors like elironrasib and zoldonrasib that are designed to suppress the growth of specific RAS-bearing cancer cells. Zoldonrasib, which targets RAS G12D, is advancing across multiple late-stage programs for PDAC and NSCLC indications. RVMD intends to move elironrasib, which targets RAS G12C, into late-stage development in NSCLC before the end of this year.
To further strengthen its position in RAS-driven cancers, Revolution Medicines has established multiple clinical collaborations to evaluate Rasonque and its other RAS inhibitors in combination regimens. These partnerships include collaborations with Bristol Myers (BMY - Free Report) , Summit Therapeutics (SMMT - Free Report) and Tango Therapeutics (TNGX - Free Report) .
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RVMD Secures FDA Win, Gets Nod for Rasonque in Pancreatic Cancer
Key Takeaways
Revolution Medicines (RVMD - Free Report) announced that the FDA has approved its RAS inhibitor daraxonrasib for previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The drug will be marketed under the brand name Rasonque.
Why the Approval Is a Big Deal for RVMD
The approval marks a major inflection point for Revolution Medicines, making Rasonque the company’s first marketed product and transforming it from a clinical-stage biotech into a commercial-stage oncology company.
The FDA’s decision is supported by data from the phase III RASolute 302 study, which met all its primary and secondary endpoints. Recently, Revolution Medicines reported full results from this study, which showed that daraxonrasib reduced the risk of death by 60% compared with cytotoxic chemotherapy and nearly doubled median overall survival. The treatment also significantly improved progression-free survival and quality-of-life measures.
Beyond its efficacy, however, Rasonque could have another important advantage over chemotherapy — greater convenience of administration. The drug is available as a once-daily oral tablet, whereas the chemotherapy regimens used in RASolute 302 required intravenous administration.
As a result, Rasonque could challenge cytotoxic chemotherapy as a preferred treatment option in previously treated metastatic PDAC, an area with limited treatment options. Its combination of once-daily oral administration, improved clinical outcomes and favorable patient-reported quality-of-life results could make it an attractive alternative to conventional chemotherapy in this setting.
The approval comes a month after the FDA accepted the regulatory submission for the drug. The agency reviewed the filing under the Commissioner’s National Priority Voucher pilot program, which is designed to accelerate the review process and targets a review timeline of one to two months.
RVMD Stock’s Price Performance
Despite the positive announcement, investor reaction to the stock remained muted yesterday. This was likely due to the wholesale acquisition cost of $39,800 set by the company for a 30-day supply of the drug, which was higher than what investors had initially been expecting.
Year to date, the company’s shares have skyrocketed 177% compared with the industry’s 12% growth.
Image Source: Zacks Investment Research
FDA Approval Validates RVMD’s RAS Pipeline
The approval also strengthens Revolution Medicines’ position in RAS-driven cancers and provides a commercial foundation for advancing its broader oncology pipeline. Rasonque is designed to target a broad spectrum of RAS-driven cancers, including PDAC, non-small cell lung cancer (NSCLC) and colorectal cancer.
Beyond the currently approved indication, Revolution Medicines is evaluating the drug inseveral other PDAC settings in late-stage studies. While the RASolute 303 study is assessing the drug for the first-line metastatic setting of the disease, the RASolute 304 study is evaluating its efficacy as an adjuvant therapy for patients with resectable PDAC.
The company is also conducting the phase III RASolve 301 study, which is evaluating Rasonque in patients with locally advanced or metastatic RAS-mutated NSCLC. Initial data from this study are expected next year.
Revolution Medicines is also developing mutant-selective inhibitors like elironrasib and zoldonrasib that are designed to suppress the growth of specific RAS-bearing cancer cells. Zoldonrasib, which targets RAS G12D, is advancing across multiple late-stage programs for PDAC and NSCLC indications. RVMD intends to move elironrasib, which targets RAS G12C, into late-stage development in NSCLC before the end of this year.
To further strengthen its position in RAS-driven cancers, Revolution Medicines has established multiple clinical collaborations to evaluate Rasonque and its other RAS inhibitors in combination regimens. These partnerships include collaborations with Bristol Myers (BMY - Free Report) , Summit Therapeutics (SMMT - Free Report) and Tango Therapeutics (TNGX - Free Report) .
Revolution Medicines, Inc. Price
Revolution Medicines, Inc. price | Revolution Medicines, Inc. Quote
RVMD’s Zacks Rank
Revolution Medicines currently has a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.