Three cancer drugs separately earned FDA approval : The KRAS inhibitor sotorasib (Lumakras; Amgen) was approved for use with the EGFR inhibitor panitumumab (Vectibix; Amgen) to treat patients with metastatic colorectal cancer with a KRAS G12C mutation. Regulators based their decision on results of the phase III CodeBreaK 300 trial in which progression-free survival (PFS) was 5.6 months for those who received the combination versus 2 months for those who received investigator’s choice standard trifluridine/tipiracil or regorafenib (Stivarga; Bayer). The Bruton tyrosine kinase inhibitor acalabrutinib (Calquence; AstraZeneca) was approved for use with bendamustine and the anti-CD20 mAb rituximab (BR) to treat adults newly diagnosed with mantle cell lymphoma (MCL). In the phase III ECHO trial, that combination led to a 32% improvement in PFS over a placebo plus BR, but it elicited serious adverse reactions in 69% of patients. Regulators also greenlighted datopotamab deruxtecan (Datroway; Daiichi Sankyo) for adults with inoperable, metastatic HR-positive, HER2 - negative breast cancer who’ve already received an endrocrine-based therapy and chemotherapy. The TROP2-directed antibody–drug conjugate improved PFS by 2 months over investigator’s choice of chemotherapy but yielded no significant improvement in overall survival.

NCI Director W. Kimryn Rathmell, MD, PhD, announced today that she will step down effective Monday, January 20, the same day Donald Trump will be inaugurated as president. Rathmell, who had previously served as chair of the Department of Medicine at Vanderbilt University in Nashville, TN, began her NCI tenure in December 2023. Additionally, today is Monica Bertagnolli, MD’s, final day as the NIH director, a role she has held since November 2023. Bertagnolli preceded Rathmell as NCI director, prior to which she was a surgeon at Brigham and Women’s Hospital in Boston, MA.

Although it has risen from 7% over the past decade, the relative 5-year survival rate for pancreatic cancer is 13% , the same rate as reported last year, according to the just released American Cancer Society’s Cancer Facts & Figures, 2025 report. Patients with pancreatic adenocarcinoma, the most common form of the disease, have just an 8% 5-year survival rate. About 67,440 Americans will be diagnosed with pancreatic cancer this year, and 51,980 are predicted to die from it.

The FDA will prohibit the use of the red food dye FD&C Red No. 3 , also known as erythrosine or Red 3, in foods and ingested drugs. The decision comes in response to a 2022 petition asking the agency to review whether the dye should be banned under the Delaney Clause, which prohibits FDA authorization of a food or color additive found to cause cancer in humans or animals. Studies have shown that exposure to high levels of Red No. 3 causes cancer in rats, although rats have a specific hormonal mechanism not present in humans. Manufacturers who use Red No. 3 in food and ingested drugs will have until January 15, 2027, or January 18, 2028, respectively, to reformulate their products.

AbbVie bought the rights to SIM0500 , a trispecific T-cell engager for multiple myeloma, from Chinese pharmaceutical company Simcere Zaiming for an undisclosed upfront payment and up to $1.05 billion if development milestones are met. SIM0500 binds to GPRC5D and BCMA, cell-surface proteins expressed in multiple myeloma, and CD3, which is expressed on T cells, forcing T cells to attack the cancer cells. The drug is in phase I trials in both the United States and China.

GSK will acquire IDRx , a Boston, MA–based biopharmaceutical company that specializes in developing therapeutics for gastrointestinal stromal tumors (GIST), a rare soft tissue sarcoma often caused by KIT mutations. As part of the deal, GSK will pay $1 billion upfront and up to $150 million more if development milestones are met and will acquire IDRX-42, a KIT-directed tyrosine kinase inhibitor. In November, IDRx announced that the drug elicited an objective response of 29% in a phase I/Ib trial of patients (25 of 87) with GIST.

Eli Lilly will acquire STX-478 , a PI3Kα inhibitor for breast cancer and other solid tumors, from Scorpion Therapeutics in a deal that could be worth up to $2.5 billion for Scorpion and its shareholders if development and commercialization milestones are met. Eli Lilly will acquire Scorpion, which will form a new entity to retain its employees and non–PI3Kα-related assets. In a phase I/II study, the results of which were reported in September, STX-478 elicited an objective response in 23% (five of 22) patients with HR-positive, HER2-negative breast cancer, and 44% (four of nine) patients with gynecologic cancers ( Ann Oncol 2024;35:S1220 ).

The Chordoma Foundation and some of its philanthropic partners announced that they will launch a competition offering $500,000 in prizes for the discovery of drugs targeting the protein TBXT, a transcription factor long considered undruggable. TBXT is crucial for the development of the spinal cord and is commonly mutated in chordoma—a rare bone tumor that forms in the spine or skull—and in breast, lung, colon, and prostate tumors. Prizes of $250,000 and $100,000 will be awarded for compounds that bind TBXT, depending on the chemical affinity between the two molecules.

Cambridge, MA–based Mersana Therapeutics announced today that its B7-H4–targeted antibody–drug conjugate emilatug ledadotin (XMT-1660) elicited a complete response in 23% (six of 26) of patients with triple-negative breast cancer in a phase I trial. None of the patients, who had received a median of 4.5 prior therapies, developed grade 4 or 5 treatment-related adverse events (TRAE); the most common TRAEs were increases in liver enzymes and protein, experienced by 38% and 31% of patients, respectively. B7-H4 is a transmembrane glycoprotein expressed in low levels in normal tissues but upregulated in some solid tumors—notably cholangiocarcinoma and breast, ovarian, and endometrial cancers—and linked with a poor prognosis.

Of 3,066 patients with B-cell lymphoma, acute lymphoblastic leukemia, or multiple myeloma who received chimeric antigen receptor (CAR) T-cell therapy over a 6-year period, only one developed a T-cell cancer following treatment , according to a French study, suggesting that the risk of these malignancies after CAR T-cell therapy is very low ( Nat Med 2025 Jan 08 [Epub ahead of print] ). The patient was diagnosed with anaplastic lymphoma 3 years after receiving tisagenlecleucel (Kymriah; Novartis) for diffuse large B-cell lymphoma and was found to have an integration of a CAR transgene into a tumor suppressor gene. Concerns over secondary malignancies associated with CAR T-cell therapy prompted the FDA to require black box safety warnings on them last year, although other studies have also found only a minimal link between the therapy class and secondary cancers ( Cancer Discov 2024 Feb 01 [Epub] ) .

Johnson & Johnson announced today that the combination of amivantamab (Rybrevant) and lazertinib (Lazcluze) showed a significant overall survival (OS) improvement compared with osimertinib (Tagrisso; AstraZeneca) in patients with non–small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R substitution mutations in the phase III MARIPOSA study. Amivantamab is a bispecific mAb targeting EGFR and MET, and lazertinib and osimertinib are both EGFR inhibitors; osimertinib is the standard-of-care for newly diagnosed patients with EGFR -mutated NSCLC. The relative improvement in median OS is expected to exceed 1 year, according to the company, which will report the specifics at an upcoming major medical meeting. Researchers already reported that patients receiving the combination had a median progression-free survival of 23.7 months, compared with 16.6 months in patients who received osimertinib ( Cancer Discov 2023;13:OF9 ).

Boston, MA–based Dana-Farber Cancer Institute (DFCI) today announced the launch of the Center for RAS Therapeutics , an initiative that aims to advance new treatments for patients with RAS -mutant cancers through collaborations between Dana-Farber researchers, industry, and other academic medical centers. RAS mutations are found in 20% of all cancers and are a major driver of certain malignancies, such as pancreatic and colorectal cancers. The program, which will support pre-clinical studies and clinical trials of RAS-directed therapies, will be directed by DFCI’s Chief of Strategic Partnerships Alice Shaw, MD, PhD, and Andrew Aguirre, MD, PhD, a gastrointestinal oncologist and pancreatic cancer researcher.

U.S. Surgeon General Vivek Murthy, MD, released an advisory today highlighting the link between alcohol consumption and cancer risk . After tobacco and obesity, alcohol use is the leading preventable cause of cancer in the United States, contributing to nearly 100,000 cases and 20,000 deaths annually, the advisory notes. However, less than half of U.S. adults are aware of the causal relationship between alcohol and cancer risk, which has been well-established for breast, colorectal, esophageal, liver, mouth, throat, and larynx cancers. The advisory makes several recommendations for reducing alcohol-related cancers, including updating the Surgeon General’s health warning label on alcoholic beverages to include a warning about cancer risks––a power that lies with Congress.

Innovent Biologics will license IBI3009 , its investigational DLL3-targeted antibody–drug conjugate (ADC) for small cell lung cancer (SCLC), to Roche for $80 million upfront and payments totaling up to $1 billion if development and commercialization milestones are reached. DLL3 is a cell-surface antigen expressed at high levels in certain cancers, including more than 80% of SCLCs. The first patient with SCLC received IBI3009 in a phase I trial in December 2024, which will also enroll patients with neuroendocrine carcinomas.

Bristol Myers Squibb announced that the FDA approved nivolumab and hyaluronidase (Opdivo Qvantig) for subcutaneous injection across all currently approved solid tumor indications for intravenous (IV) nivolumab (Opdivo), including renal cell carcinoma, melanoma, non–small cell lung cancer, and numerous others. The PD-1 inhibitor plus hyaluronidase, which helps the body absorb injected drugs, can be used as a monotherapy or monotherapy maintenance treatment, or in combination with chemotherapy or cabozantinib (Cometriq; Exelixis), a multi-tyrosine kinase inhibitor. The decision was based on the phase III CheckMate 67T study, which pitted subcutaneous nivolumab and hyaluronidase against IV nivolumab in patients with small cell renal cell carcinoma; 24% of patients receiving both agents subcutaneously achieved an overall response, compared with 18% of those receiving nivolumab intravenously.

The anti-PD-1 mAb tislelizumab (Tevimbra; BeiGene) earned FDA approval for gastric and gastroesophageal junction cancers in combination with chemotherapy, following its approval earlier this year for patients with esophageal squamous cell carcinoma. The new approval is based on results from the phase III RATIONALE-305 study, in which 997 patients received either tislelizumab plus chemotherapy or placebo plus chemotherapy. Median overall survival was 15 months in the tislelizumab group and 12.9 months in the placebo group.

After the U.S. Congress pulled funding for a few pediatric cancer programs from the bill passed last week to fund the government through March 14, the Senate voted unanimously to restore a $12.6 million annual allocation for childhood cancer research  for 5 years. The vote extends the Gabriella Miller Kids First Research Act, enacted in 2014 and named for a 10-year-old girl who died from an inoperable brain tumor, which directs funding to the NIH for pediatric cancer research. According to the act, the funding will support “important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis.”  Because the U.S. House approved the funding extension last March, only the Senate needed to give the final approval.

Innovent Biologics’ ROS1 tyrosine kinase inhibitor (TKI) taletrectinib adipate (Dovbleron) was approved by the National Medical Products Administration, the Chinese equivalent of the FDA, for patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC) previously treated with ROS1 TKIs. In the single-arm, phase II TRUST-I study, 51.5% of TKI-pretreated patients who already took a TKI and then received taletrectinib adipate experienced tumor shrinkage; median progression-free survival was 7.6 months. The drug has received orphan drug and breakthrough therapy designations from the FDA and is under consideration for approval for the same indication.

The FDA granted accelerated approval to encorafenib (Braftovi; Array BioPharma/Pfizer), a BRAF inhibitor, in combination with the anti-EGFR mAb cetuximab (Erbitux; Eli Lilly) and the chemotherapy regimen mFOLFOX6 for patients with metastatic colorectal cancer  harboring a BRAF V600E mutation. The decision was based on results from the phase III BREAKWATER trial, in which 61% of patients with metastatic disease receiving encorafenib, cetuximab, and mFOLFOX6 responded to the drug regimen, compared with 40% of patients receiving chemotherapy with or without the anti-VEGF mAb bevacizumab (Avastin; Genentech). The approval is the first to be granted under Project FrontRunner, an FDA initiative that aims to encourage drugmakers to seek accelerated approval of drugs as first-line treatments for patients with advanced or metastatic disease. Encorafenib was originally approved to treat inoperable or metastatic melanoma and garnered approval for the treatment of metastatic non–small cell lung cancer last year.

The U.S. government is headed toward a shutdown after a bill to extend the federal government’s funding was scrapped by House Speaker Mike Johnson following pressure from Elon Musk and President-elect Donald Trump. Without a new bill approved by both houses of Congress and President Joe Biden, funding will end at 12:01 am on Saturday, December 21, for many agencies and departments, including the FDA, NIH, and NCI. The bill, known as a continuing resolution, would have extended funding until March 14. Musk and Trump objected to the bill’s size and scope, which included billions of dollars in funding for disaster relief, aid to farmers, and other provisions beyond maintaining fiscal year 2024 spending levels.