A Year of Advancements in the Treatment of Cancer

The field of cancer treatment saw a variety of advancements in 2025, from new dedicated centers to approved treatments to novel therapies. In this overview, PharmTech takes a look back at significant oncology news in 2025.

What cancer drug development and approvals happened in January?

The focus on lung cancer was particularly sharp, highlighted by the European Commission’s (EC) approval on January 21 of Johnson & Johnson’s Lazcluze (lazertinib) combined with Rybrevant (amivantamab) (1). This chemotherapy-free regimen was authorized as a first-line treatment for adults with advanced non-small cell lung cancer (NSCLC) (1).

Further advancing lung cancer care, the National Institute for Health and Care Excellence in England and Wales issued positive recommendations on January 22 for two AstraZeneca treatments (2). Imfinzi (durvalumab) was recommended for adults with untreated extensive-stage small cell lung cancer when added to standard chemotherapy, having shown a sustained overall survival benefit (2). Tagrisso (osimertinib) was recommended as an adjuvant treatment option following complete tumor resection for adults with stage IB to IIIA NSCLC who have the specific EGFR mutations (2).

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) also recommended several new cancer medicines for approval in January in the European Union (3). These included Datroway (datopotamab deruxtecan) for breast cancer and Tivdak (tisotumab vedotin) for recurrent or metastatic cervical cancer (3).

Roche and Innovent Biologics announced a collaboration on January 2 to advance IBI3009, a novel delta-like ligand 3-targeted antibody drug conjugate candidate for advanced SCLC (4).

How did access to cancer drugs expand in February?

The clinical-stage radiopharmaceutical company AdvanCell successfully completed an oversubscribed $112 million Series C financing round in February (5). This funding was to be used to accelerate clinical development of its radionuclide therapy pipeline and expand the company's manufacturing capacity.

AstraZeneca’s Lynparza (olaparib) was accepted for use within National Health Services Scotland by the Scottish Medicines Consortium. This acceptance provided a new treatment option for adults with human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer who possess germline BRCA1 or BRCA2 mutations and have previously undergone chemotherapy (6).

What regulatory approvals were granted in the spring?

In late March, EMA’s CHMP recommended several medicines for extension of their therapeutic indications (7). Notably, a positive opinion was issued for Opdivo (nivolumab) for a perioperative regimen, including neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo, for resectable NSCLC in patients with PD-L1 expression. CHMP also extended indications for the cancer treatments Bosulif (bosutinib) and Calquence (acalabrutinib). The biosimilar Jubereq (denosumab) received a positive opinion for preventing skeletal-related events in adults with advanced malignancies involving bone.

In April 2025, FDA granted full approval to Bayer’s Vitrakvi (larotrectinib), a first-in-class tropomyosin receptor kinase (TRK) inhibitor (8). This approval is specifically for treating solid tumors in both adult and pediatric patients with a neurotrophic TRK gene fusion.

What infrastructure investments occurred in May?

On May 1, 2025, Aviva Capital Partners and Socius announced a substantial £1 billion investment to develop a new cancer research and treatment center in Sutton, London, located at the London Cancer Hub (9). The project aims to accelerate cancer research and contribute to the discovery and development of new diagnostic technologies and cancer drugs.

AstraZeneca announced on May 6, 2025, that Calquence (acalabrutinib) received approval in the EU (10). Acalabrutinib, a second-generation Bruton’s tyrosine kinase (BTK) inhibitor, was approved in combination with bendamustine and rituximab for treating adults with previously untreated mantle cell lymphoma who are ineligible for an autologous stem cell transplant.

On May 21, 2025, CellCentric completed a $120 million Series C funding round to advance inobrodib, a potential first-in-class oral p300/CBP inhibitor for multiple myeloma. This agent targets the reduction of transcription factors MYC and IRF4 to address therapy resistance in patients with relapsed or refractory multiple myeloma (11).

What new initiatives happened in June?

BioNTech announced plans on June 12, 2025, to acquire CureVac in an all-stock transaction valued at approximately $1.25 billion (12). This acquisition aimed to accelerate the development and manufacturing of next-generation messenger RNA (mRNA) immunotherapies for oncology by combining the strengths of the two German biotechnology companies.

Regulatory cancer treatment approvals in Europe included the following recommendations for market authorization (13):

• Zemcelpro (dorocubicel/unexpanded umbilical cord cells) received conditional marketing authorization for treating adults with hematological malignancies who require allogeneic hematopoietic stem cell transplantation when no other suitable donor cells are available.

• The orphan drug Ogsiveo (nirogacestat) was approved for the treatment of adults with progressing desmoid tumors.

• The biosimilar Vivlipeg (pegfilgrastim) received a positive opinion for reducing the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.

Priothera was awarded nearly €1.7 million in non-dilutive funding via a French government innovation competition (i-Nov) (14). This funding will support a clinical program evaluating its novel oral S1P receptor modulator, mocravimod, as an addition to commercial CAR-T cell therapies for hematologic malignancies.

Poland-based CDMO Mabion announced a €500,000 oncology services contest at the BIO 2025 convention in June (15). The contest aims to accelerate the development of recombinant protein-based cancer therapies, offering the winner credit toward Mabion’s end-to-end CDMO services.

Were there advancements in radiopharmaceutical therapies?

August 2025 saw the publication of a new FDA draft guidance concerning oncology therapeutic radiopharmaceuticals (RPTs) (16, 17). Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development was created to help drug sponsors identify an optimized dosage for RPTs used in oncology indications during clinical development.

Radiopharmaceuticals have evolved from treating superficial tumors to treating internal tumors. FDA's new guidance signals an increasing need for drug sponsors to demonstrate a better understanding of pharmacodynamics, potential toxicity liabilities, and the therapeutic window for these new systemically injected therapies, alongside designing clinical trials to gather data on dosimetry (17).

Did oncology pipelines expand in 2025?

On July 28, 2025, GSK announced that it entered into agreements with Hengrui Pharma to develop treatments for several therapeutic areas, including new therapies for GSK’s oncology pipeline (18).The collaboration included 11 programs for which Hengrui Pharma will lead development through the completion of Phase I trials.

What strategies for research and manufacturing happened?

In September, the Phase IIa clinical trial for the small-molecule immunotherapy drug HTL0039732 was launched by Cancer Research UK and Nxera Pharma (19). This investigational therapy targets the EP4 receptor to address tumor-mediated immunosuppression, aiming to boost responses in resistant solid tumors. Also focused on novel approaches, Medicines Discovery Catapult (MDC) and Crown Bioscience announced a strategic partnership to create an integrated platform to accelerate the development of radiopharmaceuticals (20).

In October, AstraZeneca highlighted its advancements for medications to treat breast, bladder, and gastric cancers (21). Studies include arms of trials for trastuzumab deruxtecan (Enhertu), a Phase III trial of datopotamab deruxtecan (Datroway), and final overall survival results for perioperative durvalumab (Imfinzi).

What developments were at the end of the year?

In November, the United Kingdom National Nuclear Laboratory and MDC co-led a project focused on developing next-generation cancer treatments known as Targeted Alpha Therapies (22).

In December, Johnson & Johnson's Tecvayli (teclistamab-cqyv), used in combination with daratumumab for relapsed or refractory multiple myeloma, was awarded FDA’s Commissioner’s National Priority Voucher (23) one day after Phase III MajesTEC-3 trial data were released showing the Tecvayli combination produced superior outcome. This voucher offers the opportunity to accelerate drug review to just 1-2 months.

Also in December, Indivumed and the Wilmot Cancer Institute at the University of Rochester Medical Center launched a joint venture to accelerate the development of novel cancer therapeutics (24). This collaboration focuses on patient-centric R&D, initially targeting advanced solid cancers.

References

1. Johnson & Johnson. European Commission Approves Lazcluze (lazertinib) in Combination with Rybrevant (amivantamab) for the First-Line Treatment of Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer. Press Release. Jan. 21, 2025.
2. AstraZeneca. AstraZeneca Receives Two Positive NICE Recommendations for Lung Cancer Patients Across England and Wales. Press Release. Jan. 22, 2025
3. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025. Press Release. Jan. 31, 2025.
4. Innovent Biologics. Innovent Enters into Exclusive Global License Agreement with Roche for Novel DLL3 Antibody Drug Conjugate. Press Release. Jan. 2, 2025.
5. AdvanCell. AdvanCell Successfully Completes an Oversubscribed US$112M Series C Financing. Press Release. Feb. 3, 2025.
6. AstraZeneca. Lynparza (olaparib) Accepted for Use in Scotland to Treat Germline BRCA-Mutated HER2-Negative Locally Advanced or Metastatic Breast Cancer After Chemotherapy. Press Release. Feb. 10, 2025.
7. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24–27 March 2025. Press Release. March 28, 2025.
8. Bayer. US FDA Grants Full Approval of Vitrakvi (larotrectinib) for Adult and Pediatric Patients with NTRK Gene Fusion-Positive Solid Tumors. Press Release. April 10, 2025. https://www.pharmtech.com/view/bayer-announces-fda-s-first-full-approval-of-ntrk-inhibitor
9. Aviva. Aviva Capital Partners and Socius Submit Plans for £1 Billion Development to Create the World’s Leading Centre for Cancer Research and Treatment. Press Release. May 1, 2025.
10. AstraZeneca. Calquence Plus Chemoimmunotherapy Approved in the EU as First and Only BTK Inhibitor for 1st-Line Mantle Cell Lymphoma. Press Release. May 6, 2025.
11. CellCentric. CellCentric Secures $120 Million Investment to Advance Inobrodib for Treating Multiple Myeloma. Press Release. May 19, 2025.
12. CureVac. BioNTech Announces Strategic Transaction to Acquire CureVac in Public Exchange Offer. Press Release. June 12, 2025.
13. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 16–19 June 2025. Press Release. June 20, 2025. https://www.pharmtech.com/view/six-biosimilars-part-of-ema-s-authorization-recommendations-in-june
14. Priothera. Priothera Secures €1.7 Million i-Nov Funding by Bpifrance for Rare Blood Cancer Clinical Program. Press Release. June 24, 2025.
15. Mabion. Mabion Launches €500,000 Services Contest to Support Next-Gen Oncology Breakthroughs. Press Release. June 17, 2025.
16. FDA. Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development. Draft Guidance for Industry (OCE, CDER, August 2025). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-therapeutic-radiopharmaceuticals-dosage-optimization-during-clinical-development
17. Haigney, S. The Impact of FDA’s Guidance on Clinical Trials for Radiopharmaceuticals. PharmTech.com. Aug. 25, 2025. https://www.pharmtech.com/view/the-impact-of-fda-s-guidance-on-clinical-trials-for-radiopharmaceuticals
18. GSK. GSK and Hengrui Pharma Enter Agreements to Develop Up to 12 Innovative Medicines Across Respiratory, Immunology & Inflammation, and Oncology. Press Release. July 28, 2025.
19. Nxera Pharma. Nxera Pharma and Cancer Research UK Announce First Patient Dosed in Phase 2a Trial of Investigational Cancer Immunotherapy HTL0039732. Press Release. Sept. 17, 2025.
20. Haigney, S. MDC and Crown Bioscience. Medicines Discovery Catapult and Crown Bioscience Form Strategic Global Alliance for Radiopharmaceutical Innovation. Press Release. Sept. 11, 2025.
21. AstraZeneca. AstraZeneca Furthers Ambition to Redefine Cancer Care with First Data from Four Major Pivotal Trials at ESMO. Press Release. Oct. 13, 2025.
22. UKNNL. UK Nuclear Revolution Powers Next-Generation Precision Cancer Therapies. Press Release. Nov. 18, 2025.
23. FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results. News release. FDA. December 15, 2025. Accessed December 15, 2025. https://www.fda.gov/news-events/press-announcements/fda-proactively-awards-national-priority-voucher-based-strong-phase-3-study-results
24. Indivumed. Indivumed and University of Rochester Medical Center Expand Collaboration for Patient-Centric Discovery of Novel Therapeutics. Press Release. Dec. 10, 2025.