FDA Oncology Approval Source Table: July 21, 2026

What this page is

The FDA publishes a running list of oncology approval notifications. Each entry gives the date, the drug, the maker, and the exact population the approval covers.

This page is a snapshot of that list covering the approvals the FDA had posted through July 21, 2026. It exists to do one thing: put the narrow official wording next to the broad headline, so the two can be compared.

The FDA's live page is linked at the bottom, and it is always more current than any snapshot.

Source table

Each row summarizes the FDA's own notification. The right-hand column lists what determines whether a given approval applies to a given person.

Date listed by FDA	What the FDA approved	What determines whether it applies
July 14, 2026	Gedatolisib (Revtorpyk, Celcuity) with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation, after progression on at least one line of endocrine therapy in the metastatic setting	Hormone receptor and HER2 status, PIK3CA test result, prior endocrine therapy, whether palbociclib is included
July 14, 2026	Traditional approval for selpercatinib (Retevmo, Eli Lilly) in adults and children aged 2 and older with locally advanced or metastatic solid tumors carrying a RET gene fusion, detected by an FDA-approved test, that have progressed on prior systemic treatment or have no satisfactory alternative	Whether RET fusion testing was done and by which test, age, prior systemic treatment
July 10, 2026	Pembrolizumab, or pembrolizumab with berahyaluronidase alfa-pmph, each with enfortumab vedotin-ejfv, as treatment before surgery and then after cystectomy for muscle invasive bladder cancer. This widened an earlier approval from cisplatin-ineligible patients to all such patients who are candidates for cystectomy	Whether the cancer is muscle invasive, whether cystectomy is planned, the sequence of treatment around surgery
July 9, 2026	Isatuximab-irfc (Sarclisa Escena, Sanofi) by subcutaneous injection for multiple myeloma indications	Route and schedule, which combination drugs are used, monitoring during administration
June 30, 2026	Allogeneic regulatory T cell-based immunotherapy with stem and progenitor cells and T cells-vldq (Tregzi, Orca Bio), for matched donor stem cell transplant with a myeloablative regimen in adults with blood cancers	Donor match, transplant regimen, transplant-center eligibility, graft-versus-host disease context
June 24, 2026	Sacituzumab govitecan-hziy (Trodelvy, Gilead) in two first-line indications for adults with triple-negative breast cancer: alone, and with pembrolizumab	Whether the cancer is triple-negative, which of the two indications applies, blood counts and infection precautions
June 24, 2026	Palbociclib (Ibrance, Pfizer) with trastuzumab, with or without pertuzumab, plus endocrine therapy, as maintenance treatment for HR-positive, HER2-positive locally advanced or metastatic breast cancer after induction treatment	Hormone receptor and HER2 status, whether induction treatment is complete, blood counts, drug interactions

The words that do the work

Approval notices repeat a small set of terms. Knowing them makes the difference between reading a headline and reading a label.

Traditional versus accelerated approval. An accelerated approval rests on an early measure, such as how many tumors shrank. A traditional approval rests on evidence of clinical benefit. The selpercatinib entry above is a conversion from one to the other.

Neoadjuvant and adjuvant. Neoadjuvant means before surgery. Adjuvant means after it. The bladder cancer entry covers both, in sequence.

Maintenance. Treatment given during a stable period to hold cancer back, rather than to shrink a tumor now.

As detected by an FDA-approved test. This clause turns a lab result into an eligibility requirement. If the test was not done, or not done with an approved assay, the indication does not apply. Our page on biomarker testing explains what these tests measure.

Line of therapy. One treatment course. Approvals often specify how many must come first, and which kinds.

Why the exact clause matters

Two of the entries above turn on a negative test result rather than a positive one. The gedatolisib approval is for breast cancer without a detected PIK3CA mutation.

That is easy to lose in a headline and it changes who is eligible completely.

Others turn on sequence. The bladder cancer approval is for a regimen given around surgery, not for advanced disease generally, and its news value is that it now covers people who can receive cisplatin as well as those who cannot.

When to raise this with your team

A new approval is worth a call when something specific lines up, not just when the cancer type matches. Concrete triggers:

• Your pathology report names the same biomarker: a RET fusion, HER2 status, hormone receptor status, or a PIK3CA result.
• You have completed the number and type of prior treatments the approval names.
• Surgery is being planned and the approval concerns treatment before or after it.
• A drug you already take is being approved in a new form, such as a subcutaneous injection instead of an infusion.

Symptoms are a separate matter and do not wait for an approval. A fever of 100.4°F (38°C) or higher during treatment that lowers blood counts is a medical emergency — contact the oncology team immediately, at any hour, and say you are on cancer treatment. New shortness of breath or chest pain means emergency care now: call 911 or go to an emergency room. Bleeding that does not stop also needs emergency care. Contact the team the same day for diarrhea that is frequent or bloody. Our page on targeted therapy covers side effects by drug class.

What this does not mean

• It does not mean anyone with the cancer type listed should receive the drug. Every row carries conditions.
• It does not compare these drugs against the other options for the same situation. An approval is a regulatory decision, not a ranking.
• It does not describe cost, insurance coverage, or whether a treatment is available nearby.
• It does not replace the full prescribing information or a care-team discussion. This page is a reading aid for the FDA's own notices, and the FDA's list is the authority.

Sources

• FDA: Oncology (Cancer) / Hematologic Malignancies Approval Notifications

How this article was prepared

An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.

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