11 New Cancer Drugs Approved: Breakthroughs in Lung Cancer, Breast Cancer and Prostate Cancer Treatment

In February 2026, several global regulatory authorities approved multiple new cancer drugs and expanded indications. These approvals came from organizations including China’s National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA), and European regulatory agencies.

The new cancer drugs approved this month cover a wide range of cancer types, including lung cancer, breast cancer, prostate cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and colorectal cancer. The therapies include targeted therapies, immunotherapies, antibody-drug conjugates (ADCs), and innovative physical treatment technologies.

HongKong DengYueMed has compiled information on 11 important new cancer drugs approved globally in February 2026, highlighting their clinical significance and therapeutic value.

Prostate Cancer New Drug: Darolutamide

Approval Date: February 3, 2026
Regulatory Authority: NMPA

Darolutamide tablets were approved in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Darolutamide is a next-generation androgen receptor (AR) inhibitor that suppresses tumor cell growth by blocking androgen receptor signaling pathways.

The approval was mainly based on the ARANOTE Phase III clinical trial. Study results showed that compared with ADT alone, darolutamide combined with ADT reduced the risk of radiographic disease progression or death by approximately 46%, while significantly prolonging progression-free survival.

Compared with some similar therapies, darolutamide has lower penetration of the blood–brain barrier, resulting in fewer central nervous system side effects such as cognitive impairment and seizures.

Clinical studies also demonstrated that the combination therapy can significantly improve overall survival and delay disease progression, providing a new treatment option for patients with metastatic prostate cancer.

Endometrial Cancer Immunotherapy New Drug: Pembrolizumab

Approval Date: February 6, 2026
Regulatory Authority: NMPA

Pembrolizumab injection received approval for a new indication in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent mismatch repair-deficient (dMMR) endometrial cancer, followed by pembrolizumab monotherapy as maintenance treatment.

Pembrolizumab is a PD-1 immune checkpoint inhibitor that works by restoring the T-cell–mediated anti-tumor immune response.

Tumors with dMMR status usually have a high mutational burden and therefore tend to respond better to immunotherapy.

Studies show that this combination regimen can improve response rates and extend progression-free survival, while maintenance therapy further prolongs disease control.

Breast Cancer New ADC Drug: Sacituzumab Tirumotecan (sac-TMT)

Approval Date: February 6, 2026
Regulatory Authority: NMPA

Sacituzumab tirumotecan was approved for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who have previously received endocrine therapy and at least one line of chemotherapy in the advanced setting.

This therapy belongs to the class of antibody-drug conjugates (ADCs).

ADC drugs use an antibody to recognize tumor-specific targets on cancer cells and deliver cytotoxic drugs directly into the tumor cells, allowing more precise tumor killing while reducing systemic toxicity.

In recent years, ADC therapies have become one of the most important advances in breast cancer treatment. Sacituzumab tirumotecan has demonstrated promising anti-tumor activity even in heavily pretreated patients, offering a new treatment option for patients with limited therapeutic choices.

Lung Cancer New Cancer Drugs: Furmonertinib, Benmelstobart, Almonertinib, Zongertinib, and Sosimerasib

Lung cancer remains the leading cause of cancer-related death worldwide. In February 2026, several new cancer drugs for lung cancer were approved or received expanded indications in different regions.

Lung Cancer Targeted Therapy New Drug: Furmonertinib

Approval Date: February 6, 2026
Regulatory Authority: NMPA

Furmonertinib received a new indication for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, whose disease progressed after platinum-based chemotherapy or who cannot tolerate chemotherapy.

EGFR exon 20 insertion mutations have long been considered one of the most difficult EGFR mutations to treat.

As a third-generation EGFR-targeted therapy, furmonertinib offers improved mutation selectivity and has shown potential advantages in controlling brain metastases, providing a new targeted therapy option for this patient population.

Lung Cancer Immunotherapy New Drug: Benmelstobart

Approval Date: February 14, 2026
Regulatory Authority: NMPA

Benmelstobart received approval for a new indication as consolidation therapy for patients with unresectable stage III NSCLC who have not experienced disease progression after platinum-based concurrent or sequential chemoradiotherapy.

The therapy is intended for patients without EGFR-sensitive mutations or ALK rearrangements.

Consolidation immunotherapy has become an important treatment strategy for stage III NSCLC, helping to prolong progression-free survival and reduce the risk of recurrence, thereby improving long-term survival outcomes.

Lung Cancer EGFR Targeted New Drug: Almonertinib Mesilate

Approval Date: February 20, 2026
Regulatory Authority: EMA

Almonertinib Mesilate was approved for the treatment of advanced NSCLC with EGFR exon 19 deletion or exon 21 (L858R) mutations, and is also effective in patients with EGFR T790M mutation-positive disease.

As a third-generation EGFR-TKI, almonertinib demonstrates strong activity against EGFR mutations while maintaining a manageable safety profile.

The drug has also shown potential benefits in controlling brain metastases, making it an important new targeted therapy for lung cancer patients.

HER2-Mutant Lung Cancer New Drug: Zongertinib

Approval Date: February 26, 2026
Regulatory Authority: FDA

Zongertinib received FDA accelerated approval for the treatment of adult patients with unresectable or metastatic non-squamous NSCLC harboring HER2 (ERBB2) tyrosine kinase domain mutations.

Although HER2 mutations occur in a relatively small proportion of lung cancer patients, treatment options for this subgroup have been limited.

Zongertinib is a selective HER2 small-molecule inhibitor, providing a new targeted treatment option for this specific population.

KRAS G12C Lung Cancer New Drug: Sosimerasib

Approval Date: February 28, 2026
Regulatory Authority: NMPA

Sosimerasib was approved for the treatment of adult patients with advanced NSCLC harboring KRAS G12C mutations who have previously received at least one systemic therapy.

KRAS mutations were historically considered undruggable targets in oncology.

The emergence of KRAS G12C inhibitors has changed this perception. Sosimerasib selectively inhibits the mutant KRAS G12C protein, blocking tumor growth signaling pathways and providing a new later-line treatment option for patients with this mutation.

Ovarian Cancer Immunotherapy New Drug: Pembrolizumab Combination Therapy

Approval Date: February 10, 2026
Regulatory Authority: FDA

The FDA approved a pembrolizumab-based treatment regimen, based on results from the KEYNOTE clinical trial series, for patients with PD-L1-positive (CPS ≥1) platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

This therapy can be used in combination with paclitaxel, with or without bevacizumab.

Treatment options for platinum-resistant ovarian cancer remain limited. Immunotherapy combined with chemotherapy may improve response rates and prolong disease control.

Pancreatic Cancer Innovative Therapy: Optune Pax®

Approval Date: February 11, 2026
Regulatory Authority: FDA

Optune Pax® tumor-treating fields therapy was approved in combination with gemcitabine and nab-paclitaxel for the first-line treatment of adults with locally advanced pancreatic cancer.

Tumor Treating Fields (TTFields) use low-intensity alternating electric fields to disrupt cancer cell division and inhibit tumor growth.

This non-invasive therapy can be used together with standard chemotherapy, providing a novel treatment strategy for pancreatic cancer patients.

Colorectal Cancer Targeted Therapy New Drug: Encorafenib Combination Therapy

Approval Date: February 24, 2026
Regulatory Authority: FDA

Encorafenib in combination with cetuximab and fluoropyrimidine-based chemotherapy was approved for patients with BRAF V600E-mutated metastatic colorectal cancer (mCRC).

BRAF V600E-mutated colorectal cancer is generally associated with poor prognosis.

By combining targeted therapy with chemotherapy, this regimen can block the MAPK signaling pathway, improve treatment response rates, and potentially enhance patient survival outcomes.

Conclusion: Global Development of New Cancer Drugs Continues to Accelerate

With the rapid advancement of precision medicine, targeted therapy, and immunotherapy, more and more new cancer drugs targeting specific genetic mutations or tumor characteristics are entering clinical practice.

✨ The approvals in February 2026 have further expanded treatment options for multiple cancers.

As a global pharmaceutical distributor, DengYueMed tracks new drug approvals from the FDA, NMPA, and European regulators, providing healthcare partners with information on innovative medicines and global supply solutions.

For more information about newly approved cancer drugs and treatment developments, feel free to contact us for further details.

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