FDA Approvals in Oncology: January-March 2026

Key Takeaways

• On March 20, 2026, FDA approved nivolumab (Opdivo) with doxorubicin, vinblastine, and dacarbazine (AVD) for previously untreated Stage III or IV classical Hodgkin lymphoma in adults and pediatric patients 12 years and older.
• On March 25, 2026, FDA approved relacorilant (Lifyorli) with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1–3 prior regimens including bevacizumab.
• On February 26, 2026, FDA granted accelerated approval to zongertinib (Hernexeos) for unresectable or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations detected by an FDA-authorized test.
• February 2026 also included traditional approval for encorafenib (Braftovi) with cetuximab and fluorouracil-based chemotherapy in BRAF V600E metastatic colorectal cancer, and acalabrutinib with venetoclax for CLL/SLL.

Which March 2026 oncology approvals changed first-line standards?

Two March labels stand out for launch modeling. FDA approved nivolumab with AVD chemotherapy on March 20, 2026, for previously untreated Stage III or IV classical Hodgkin lymphoma in patients 12 years and older. Five days later, on March 25, 2026, FDA approved relacorilant (Lifyorli), a glucocorticoid receptor antagonist, with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after one to three prior systemic regimens, at least one including bevacizumab. Lifyorli also appears on FDA’s Novel Drug Approvals for 2026 table with that March 25 date.

Primary references: FDA oncology approval notifications and FDA Novel Drug Approvals for 2026.

What February 2026 solid-tumor and hematologic labels matter for BD?

On February 26, 2026, FDA granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim) for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 tyrosine kinase domain activating mutations detected by an FDA-authorized test. On February 24, 2026, FDA granted traditional approval to encorafenib (Braftovi) with cetuximab and fluorouracil-based chemotherapy for BRAF V600E-mutant metastatic colorectal cancer, converting and expanding prior accelerated pathways. On February 19, 2026, FDA approved acalabrutinib (Calquence) with venetoclax for adults with CLL or SLL. On February 10, 2026, FDA approved pembrolizumab and subcutaneous pembrolizumab with berahyaluronidase alfa-pmph (Keytruda Qlex) with paclitaxel, with or without bevacizumab, for PD-L1–expressing platinum-resistant ovarian carcinomas.

How should commercial teams organize the Q1 2026 oncology slate?

Group the quarter by modality and setting: checkpoint combinations moving into newly diagnosed Hodgkin lymphoma; oral targeted agents requiring companion diagnostics (HER2 TKD NSCLC; BRAF V600E CRC); BTK-plus-BCL2 oral regimens in CLL/SLL; and a first-in-class glucocorticoid receptor antagonist pair in platinum-resistant ovarian cancer. Track Drugs@FDA labels for exact dosing and boxed warnings rather than relying on secondary roundups.

• March 20, 2026 — Opdivo + AVD (untreated Stage III/IV cHL)
• March 25, 2026 — Lifyorli + nab-paclitaxel (platinum-resistant ovarian/related)
• February 26, 2026 — Hernexeos accelerated approval (HER2 TKD NSCLC)
• February 24, 2026 — Braftovi traditional approval (BRAF V600E mCRC)
• February 19, 2026 — Calquence + Venclexta (CLL/SLL)

Where do these notifications sit relative to later 2026 oncology actions?

FDA’s oncology notification page continues beyond March with additional May–July 2026 breast, bladder, prostate, and hematology actions. This article intentionally scopes January–March 2026 so Q1 competitive intelligence stays separated from later PDUFA and supplemental approvals such as Veppanu (May 1, 2026) that belong in subsequent monthly digests.

What data points investors can verify on fda.gov

Concrete Q1 anchors:

• Nine-plus oncology/hematology notifications spanning February–March 2026 on FDA’s dedicated oncology page
• Lifyorli listed as novel approval number 9 for 2026 (March 25)
• Companion-diagnostic language on Hernexeos and Braftovi labels
• Age floor of 12 years on the Opdivo-AVD Hodgkin indication
• Bevacizumab prior-therapy requirement for the Lifyorli ovarian indication

What remains unproven

This rewrite deletes vague claims that Q1 2026 saw an unspecified “surge” without citing FDA’s own list. Cross-trial efficacy comparisons and peak-sales forecasts are omitted unless they appear in FDA review documents. Accelerated approvals such as Hernexeos remain contingent on confirmatory evidence.

Related NovaPharma coverage

• Notable Oncology FDA Approvals in May 2026
• May 2026 FDA Oncology Actions at a Glance
• FDA Approves Vepdegestrant (Veppanu) for ESR1-Mutated Breast Cancer

Frequently Asked Questions

Primary Sources

1. FDA: Oncology/Hematologic Malignancies Approval Notifications
2. FDA: Novel Drug Approvals for 2026
3. FDA Drugs@FDA database (label lookup for Opdivo, Lifyorli, Hernexeos)