What's New: Two FDA Approvals & Richer Emailed Results
Two FDA approvals captured the same cycle, a new map of the PI3K/AKT pathway, a landmark for mRNA cancer vaccines, and a month spent keeping every “recruiting” list honest.
Two FDA Approvals, Captured the Same Cycle
When a drug is approved, that's often the exact moment a patient or caregiver starts searching for it. Two September approvals stood out — and both represent a genuinely new idea, not just another option:
- Camizestrant (Etcamah) — a next-generation oral SERD for HR-positive, HER2-negative advanced breast cancer. What makes this approval different is how it's used: it's the first approval guided by a blood test (ctDNA) that detects an emerging
ESR1resistance mutation during ongoing hormone + CDK4/6 therapy — so treatment can be switched before the cancer visibly progresses on a scan. In its trial (SERENA-6), making that switch early roughly doubled the time without progression (median 16.8 vs 9.2 months). Its page was live within days of the decision. - Sevabertinib (Hyrnuo) — the first oral HER2 (ERBB2) tyrosine-kinase inhibitor for HER2-mutant non-small cell lung cancer. First approved for previously-treated disease, it was expanded in September to first-line use. For patients whose lung tumor carries a HER2 mutation — a group with few targeted-pill options until recently — it's a meaningful addition, with response rates around 71–75% in its studies (SOHO-01).
A New Mechanism Hub: the PI3K/AKT/mTOR Pathway
Alongside individual drug pages, we build mechanism hubs — pages that explain a whole class of therapy and gather every recruiting trial that uses it, across cancers. September's addition is the PI3K/AKT/mTOR inhibitors hub.
This pathway is one of the most commonly altered in cancer (through PIK3CA, AKT1, or PTEN changes), and it now has three FDA-approved drugs — alpelisib (Piqray), capivasertib (Truqap), and inavolisib (Itovebi) — plus a wave of next-generation, more-selective agents in trials. The hub explains how the pathway works, what the mutation tests mean, the shared side effect to know about (high blood sugar), and the recruiting trials grouped by setting. If your tumor testing mentioned any of those genes, it's a good place to start.
A Milestone for mRNA Cancer Vaccines
Personalized mRNA cancer vaccines — the same technology platform behind mRNA COVID vaccines, but custom-built to a tumor's own mutations — reached a real turning point: the first time an mRNA cancer vaccine succeeded in a Phase 3 trial. In patients with resected high-risk melanoma, adding a personalized vaccine (intismeran autogene) to immunotherapy improved both recurrence-free and distant-metastasis-free survival (the INTerpath-001 trial).
We updated our neoantigen & mRNA cancer-vaccine hub to foreground this result and refreshed its recruiting-trial landscape (pancreatic, bladder, lung, liver, breast, and pan-cancer studies). It's an emerging field, and the hub is careful to distinguish approved-and-proven from still-investigational — but this was a milestone worth marking.
A Dedicated Platinum-Resistant Ovarian Cancer Page
Ovarian cancer splits into two very different treatment situations, and the line that divides them — whether the cancer still responds to platinum chemotherapy — changes almost everything about which trials fit. So platinum-resistant disease now has its own page: platinum-resistant ovarian cancer trials. It focuses on the options that matter specifically in that setting (antibody-drug conjugates like mirvetuximab soravtansine, and other non-platinum approaches) rather than burying them in the general ovarian page.
Your Emailed Results Now Include the Actual Matches
Last month we added the ability to email your results to yourself. This month we made that email far more useful: it now contains your top trial matches as cards — each with the drug or approach, a plain-language reason it fit your profile, and buttons to read more or start a related search — instead of just a link back to the site.
Why it matters: a thorough search takes around fifteen minutes to run. If you'd rather not wait on the page, enter your email and the complete, ranked matches arrive in your inbox when they're ready — so you lose nothing by stepping away, and you have the results to read later or bring to an appointment.
Keeping Every “Recruiting” List Current
A lot of September's work is invisible but, we'd argue, among the most important: making sure a trial listed as “recruiting” actually is. Over the month we re-checked the trial counts and cited studies across more than 40 disease pages against the clinical-trials registry — re-verifying each page's numbers, relabeling trials that moved to “not yet” or “no longer” recruiting, and only updating a page when the underlying data actually changed (not just the date). The goal is simple: when a page says there are N recruiting trials for your cancer, that should be true today, not three months ago.
Sharper Matching & Smaller Improvements
As usual, much of the month's work isn't a new page — it's making the matching and the site itself more precise and easier to use:
- Matching to KRAS-targeted trials by subtype. The questionnaire now captures your specific KRAS subtype (such as G12C or G12D), not just “KRAS-positive” — so it can match you to the right targeted trials from the fast-moving KRAS drug wave (sotorasib and adagrasib for G12C; daraxonrasib and others for G12D) across pancreatic, colorectal, lung, and biliary cancers.
- More consistent biomarker-aware matching. The system now reconciles the biomarker signals in your profile after scoring, so conflicting or redundant biomarker details are handled consistently — across every line of therapy, not just the first.
- More accurate staging. We fixed a bug where the questionnaire could collapse distinct disease sub-stages that happen to share a number — so your stage is captured the way you entered it.
- Easier navigation of long pages. Disease, drug, and mechanism pages now have a sticky table-of-contents sidebar, so you can jump straight to the section you need instead of scrolling.
- Evidence while you wait. The search progress screen now renders the supporting evidence behind a match as it's prepared.
- Privacy, tightened. Your pasted medical description is no longer included in the behind-the-scenes requests for individual trial details; emailed results go only to the address on file (with a daily limit); and the free-form “paste your summary” path now asks for the same clear, two-part consent as the guided questionnaire — so you always know what you're agreeing to before anything is processed.
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