FDA Activity Round Up July 2026
This FDA Activity Round Up July 2026 summarizes mid-month oncology decisions posted on fda.gov. Highlights include gedatolisib for breast cancer, traditional approval of selpercatinib for RET fusion-positive solid tumors, a Keytruda–Padcev muscle-invasive bladder cancer expansion, and subcutaneous isatuximab.
Contents11 sections
Key Takeaways
- July 14: FDA approved gedatolisib (Revtorpyk) with fulvestrant ± palbociclib for HR+/HER2- PIK3CA wild-type advanced breast cancer.
- July 14: FDA granted traditional approval to selpercatinib (Retevmo) for RET fusion-positive solid tumors in patients ≥2 years.
- July 10: Keytruda or Keytruda Qlex plus Padcev gained perioperative MIBC use for cystectomy candidates, not only cisplatin-ineligible patients.
- July 9: FDA approved isatuximab-irfc (Sarclisa Escena) for subcutaneous injection across listed multiple myeloma combinations.
July 2026 FDA oncology actions at a glance
| Date | Action | Product | Sponsor |
|---|---|---|---|
| July 14, 2026 | New approval (combination use) | Gedatolisib (Revtorpyk) + fulvestrant ± palbociclib | Celcuity Inc. |
| July 14, 2026 | Traditional approval (prior accelerated) | Selpercatinib (Retevmo) for RET fusion+ solid tumors | Eli Lilly and Company |
| July 10, 2026 | Indication expansion | Pembrolizumab / Keytruda Qlex + enfortumab vedotin (MIBC) | Merck; Astellas (Padcev) |
| July 9, 2026 | New formulation / route | Isatuximab-irfc SC (Sarclisa Escena) | Sanofi-Aventis U.S. |
What breast cancer decision did FDA post on July 14?
On July 14, 2026, FDA approved gedatolisib (Revtorpyk, Celcuity) with fulvestrant, with or without palbociclib, for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation after progression on or after at least one line of endocrine therapy in the metastatic setting.
Efficacy came from VIKTORIA-1 Study 1 (NCT05501886): median PFS 9.3 months for the triplet and 7.4 months for the doublet versus 2.0 months with fulvestrant alone. See FDA's gedatolisib approval notice.
What did traditional approval of selpercatinib change?
Also on July 14, 2026, FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adults and children two years and older with locally advanced or metastatic solid tumors harboring a RET gene fusion, as detected by an FDA-approved test, after prior systemic treatment or when no satisfactory alternative exists.
Accelerated approval for adults dates to 2022, with a pediatric expansion in 2024. Conversion rested on LIBRETTO-001 (NCT03157128) and supportive pediatric data from LIBRETTO-121 (NCT03899792). In 75 patients with RET fusion-positive tumors other than NSCLC and thyroid cancer, ORR was 47% and median duration of response was 24.5 months, per FDA's selpercatinib traditional-approval page.
How did Keytruda–Padcev expand in bladder cancer?
On July 10, 2026, FDA approved pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), each with enfortumab vedotin-ejfv (Padcev), as neoadjuvant therapy followed by adjuvant therapy after cystectomy for adults with muscle-invasive bladder cancer (MIBC).
The action extends prior use in this setting from cisplatin-ineligible patients to all MIBC patients who are candidates for cystectomy. KEYNOTE-B15/EV-304 (NCT04700124) randomized 808 cisplatin-eligible patients; perioperative pembrolizumab plus enfortumab vedotin improved event-free survival (HR 0.53) and overall survival (HR 0.65) versus neoadjuvant gemcitabine–cisplatin. Details are on FDA's July 10 Keytruda–Padcev MIBC page.
What is new with Sarclisa Escena?
On July 9, 2026, FDA approved isatuximab-irfc (Sarclisa Escena, Sanofi) for subcutaneous injection for multiple myeloma indications that mirror listed combination regimens: with pomalidomide–dexamethasone after prior lenalidomide and a proteasome inhibitor; with carfilzomib–dexamethasone in relapsed/refractory disease after one to three prior lines; and with bortezomib–lenalidomide–dexamethasone in newly diagnosed transplant-ineligible patients.
IRAKLIA (NCT05405166) supported non-inferior overall response for subcutaneous versus intravenous isatuximab with pomalidomide–dexamethasone (ORR 71.1% vs 70.5%). See FDA's Sarclisa Escena approval notice.
What should readers watch next?
These July actions cluster in oncology labeling updates rather than a single novel-drug wave. Sponsors still need to post full prescribing information on Drugs@FDA as labels finalize. Cross-check warnings — hepatotoxicity and ILD for selpercatinib, known Keytruda and Padcev toxicities, and infusion/injection reactions for isatuximab — before care decisions.
For process and safety context beyond this roundup, see FDA human-factors guidance for marketing submissions and our January 2026 Salmonella moringa leaf powder recall note.
What this roundup does not cover
This piece is limited to verified July 2026 FDA oncology/hematology approval notifications on fda.gov. It does not invent CNPV or LIPFENDRA actions that lack a matching FDA page in this window, and it is not a complete CDER calendar of every ANDA or labeling supplement.
Related NovaPharma coverage
- J&J Phase 3 Tremfya ulcerative colitis data
- Moderna mRNA-1083 Phase 3 flu/COVID response
- Chile warning labels and obesity-risk evidence
Frequently Asked Questions
What are the main FDA oncology actions in July 2026?
In mid-July 2026 the FDA approved gedatolisib (Revtorpyk) for HR+/HER2- PIK3CA wild-type advanced breast cancer, granted traditional approval to selpercatinib for RET fusion-positive solid tumors, expanded Keytruda–Padcev for muscle-invasive bladder cancer, and approved subcutaneous isatuximab-irfc (Sarclisa Escena).
When did the FDA approve gedatolisib (Revtorpyk)?
On July 14, 2026, the FDA approved gedatolisib with fulvestrant, with or without palbociclib, for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation after at least one metastatic endocrine therapy line.
What changed for Keytruda and Padcev in July 2026?
On July 10, 2026, the FDA approved pembrolizumab or Keytruda Qlex each with enfortumab vedotin-ejfv as neoadjuvant then adjuvant therapy around cystectomy for adults with muscle-invasive bladder cancer, extending the regimen beyond cisplatin-ineligible patients to all cystectomy candidates in that setting.
Primary Sources
This article follows our editorial standards. Report a correction via editorial contact.
