Oncology News & Updates

FDA Approvals

• FDA Approves Zidesamtinib for ROS1-Positive Non-Small Cell Lung Cancer

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Updates from ASCO

• The Centers for Medicare & Medicaid Services has released its 2027 proposed rule for the Medicare Physician Fee Schedule, which ASCO estimates will result in a 1.5% overall reimbursement cut for the hematology/oncology specialty. Read ASCO's analysis of the proposed rule, including updates on the conversion factor, the G2211 complexity add-on code, and changes to the Quality Payment Program.
  

• State Affiliate Update: Tools, Advocacy, and Resources from ASCO

• Momentum Building for Bipartisan Prior Authorization Reform Bill

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Corporate Member News

• The Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. Selpercatinib received accelerated approval for this indication for adult patients in 2022 and for pediatric patients two years of age and older in 2024.

Coding and Reimbursement Updates

• This Month’s E-Reiumbursement Newsletter from Bobbi Buell contains updates on  Eli Lilly’s 340B pricing showdown, complex new Medicare drug renegotiation rules, and stricter Medicaid work requirements. It also offers practical strategies to combat predatory insurance downcoding and previews upcoming federal policy changes.

Coding and Reimbursement Updates

• This Month’s E-Reiumbursement Newsletter from Bobbi Buell contains updates on upcoming July HCPCS code changes, braces providers for chaotic 2027 ACA policy shifts that risk leaving patients uninsured mid-treatment, and highlights a discouraging AMA survey proving that prior authorization headaches and their adverse effects on patients remain stubbornly unresolved by AI.

Corporate Member News

• Kura Oncology and Kyowa Kirin Announce Publication in Blood of Ziftomenib plus Venetoclax / Azacitidine Combination in Patients with R/R NPM1-m AML.

Press Release  Publication

• The Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

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• Updated 1L mTNBC recommendations from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer from Gilead Oncology

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• The Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test.

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• The Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.

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• The Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two indications in adults with triple-negative breast cancer (TNBC). The first indication, supported by ASCENT-03, is for sacituzumab govitecan-hziy as a single agent for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor-based therapy.

News from ASCO

• Standing Ovation Erupts at ASCO 2026 for Game-Changing Pancreatic Cancer Data.

• CMS Releases Medicaid Work Requirement Guidance; ASCO Emphasizes Need for Exemptions for Cancer Diagnosis.

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Institutional Member News

New Clinical Trials Now Open at UC Davis Comprehensive Cancer Center:

MCLA-158-CL02 — Head & Neck
A Phase 3 randomized study evaluating petosemtamab versus investigator's choice monotherapy in patients with previously treated, incurable metastatic/recurrent head and neck squamous cell carcinoma (HNSCC) who have progressed on anti-PD-1 and platinum-based therapy.

BCA101X301 — Head & Neck
A Phase 2/3 randomized, double-blind study of ficerafusp alfa (BCA101), a dual EGFR/TGF-β targeting agent, in combination with pembrolizumab for first-line treatment of PD-L1-positive recurrent or metastatic HNSCC.

UCLA-L-11 — Thoracic
A Phase 2 trial evaluating ivonescimab, a monoclonal antibody, in patients with previously treated thymic carcinoma, measuring overall response rate, safety, and long-term outcomes including progression-free and overall survival.

ZL-1310-003 — Thoracic
A Phase 3 randomized study comparing ZL-1310, a DLL3 antibody-drug conjugate (ADC), to investigator's choice chemotherapy in patients with relapsed small cell lung cancer. Phase 1 data showed a 68% objective response rate and promising intracranial activity.

For referrals or more information, contact UC Davis Comprehensive Cancer Center's Office of Clinical Research at OCRReferral@health.ucdavis.edu or 916-382-6970.

Advocacy News

California Committee Advances Copay Accumulator Bill.  The California Senate Committee on Health unanimously advanced SB 1199, legislation that. would ban copay accumulator programs, on April 22. ASCO supported the bill along with the  Association of Northern California Oncologists and the Medical Oncology Association of Southern California. 

Corporate Member News

• Bristol Myers Squibb invites ANCO members to join them at ASCO for their 7th annual gathering to discuss ongoing efforts to Conquer Veteran Cancer, Together.  The event will take place on Sunday, May 31, 2026, from 9:30–11:30 AM CT at the Hyatt Regency McCormick Place (Regency Ballroom AB).

• Tarlatamab-dlle (IMDELLTRA®) is an NCCN® Category 1, Preferred subsequent treatment for adult patients (PS 0-2) with ES-SCLC who have progressed on or after platinum-based chemotherapy.  To access the full recommendations, please visit the NCCN® website: SCLC Guidelines.

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• FDA approves Lumakras® (sotorasib), Amgen in combination with vectibix® (panitumumab) for chemorefractory kras G12C-mutated metastatic colorectal cancer.

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• FDA grants full approval to Amgen's IMDELLTRA® in extensive stage small cell lung cancer. 

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• BeOne Medicines received accelerated approval from the Food and Drug Administration for Beqalzi, a treatment aimed at certain lymphoma patients.

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• The Food and Drug Administration approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.

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• The Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test.

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• The Food and Drug Administration approves DECNUPAZ™ (pivekimab sunirine-pvzy) for Treatment of Adult Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm, an Ultra-Rare and Aggressive Blood Cancer With Limited Treatment Options.

Coding and Reimbursement Updates

• This Month’s E-Reiumbursement Newsletter from Bobbi Buell for April 23, 2026

Coding and Reimbursement Updates

This Month’s E-Reiumbursement Newsletter from Bobbi Buell for March 31, 2026

Clinical Trial News from UC Davis

This is a phase 1 study evaluating the safety and feasibility of laser interstitial thermal therapy (LITT) followed by lomustine (CCNU) for recurrent glioblastoma in adults. 

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This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

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Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy for the Treatment of Patients With Locally Recurrent, Refractory or Oligometastatic Head and Neck Squamous Cell Carcinoma.

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Corporate Member News

FDA Approves Corcept’s Selective Glucocorticoid Receptor Antagonist Lifyorli™ (relacorilant) Plus Nab-Paclitaxel for Treatment of Patients with Platinum-Resistant Ovarian Cancer

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Pfizer Oncology is pleased to announce that the FDA has updated the Prescribing Information for BRAFTOVI® (encorafenib) on February 24, 2026 to include new data with an expanded indication.

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Takeda, AstraZeneca, and Daiichi Sankyo, were recently highlighted in the report, "Oncology Drugs Fast-Tracked and Prioritized by the FDA in March 2026."

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Updates from ASCO

ASCO has urged CMS to delay the October 1, 2026, launch of the GLOBE drug pricing model until the administration can better evaluate its potential impact on oncology practices. While supporting lower patient costs, the association remains concerned that the new benchmark could unintentionally restrict access to critical cancer care.

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Molecular Inference–Based Deep Learning Assesses CNS Tumor Diagnosis: The accuracy of a hierarchical molecular inference–based deep-learning system, Neuropath-AI, was tested in central nervous system tumor diagnosis and classifications in a retrospective study. ASCO to Update Guideline for Multiple Myeloma.

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Corporate Member News

Bristol Myers Squibb Announces Positive Phase 3 Results from the SUCCESSOR-2 Study of Oral Mezigdomide in Relapsed or Refractory Multiple Myeloma.

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Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line.

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Institutional News

• A Phase II Study of Amivantamab SC (Subcutaneous) in Participants With MET Amplification-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)  This phase II Expanded Lung-MAP treatment trial tests how well amivantamab-subcutaneous (SC) works in patients with MET amplification non-small cell lung cancer. Amivantamab-SC is a drug directed against the MET gene. The primary objective is to evaluate the objective response rate (ORR).  

Click her to see the study protocol

For more information or to refer a patient, please contact UC Davis Comprehensive Cancer Center, Office of Clinical Research via email at OCRReferral@health.ucdavis.edu or by phone at 916-382-6970.

Updates from ASCO

The American Society of Clinical Oncology and Conexiant have launched ASCO AI in Oncology, a new digital platform dedicated to helping oncology professionals navigate the rapidly evolving world of artificial intelligence. This trusted resource provides curated, expert-led insights, practical education on enhancing diagnostic accuracy and workflows, and a space for global clinicians to share real-world implementation experiences.  READ MORE

“Massive Shift” Prompts ASCO to Update Guideline for Multiple Myeloma.

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New data published in the American Cancer Society’s (ACS) Cancer Statistics, 2026 report show that, for the first time, the 5-year survival rate for all cancers combined has reached 70% for individuals diagnosed during 2015 to 2021 in the United States. In addition, those diagnosed with high-mortality cancers and advanced diagnoses experienced the largest gains in survival.

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Corporate Member News

FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

FDA approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.

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New Publication Alert: Learn More About Real-World Outcomes in ER+/HER2- ESR1-Mutant Metastatic Breast Cancer

Clinical Cancer Research has recently featured two complimentary publications detailing the outcomes of patients administered an oral SERD with ESR1-mutant metastatic breast cancer

Lloyd et al., 2025

Rugo et al., 2025 

Coding and Reimbursement Updates

This Month’s E-Reiumbursement Newsletter from Bobbi Buell for January 2026.

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FDA Approvals

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Updates from ASCO

ASCO Chief Medical Officer Julie Gralow warns that unstable federal funding is causing a "cancer brain drain" that threatens America’s scientific leadership and the future of life-saving breakthroughs.

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Rates of multiple myeloma, the second most common blood cancer in the United States, are increasing and are twice as high in men than in women. A new study published in the journal Cancer provides insights that may help to explain this disparity.

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The Centers for Medicare & Medicaid Services released two proposed drug pricing models—Global Benchmark for Efficient Drug Pricing (GLOBE) and Guarding U.S. Medicare Against Rising Drug Costs (GUARD)—intended to reduce Medicare spending by aligning U.S. drug prices with international pricing benchmarks. Both models target high-cost, single-source drugs, which includes many chemotherapy and immunotherapy agents.

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FDA Approvals

The Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024).

Coding and Reimbursement Updates

This Month’s E-Reiumbursement Newsletter from Bobbi Buell for October 29, 2025. In this edition:  TrumpRx, New CPT Codes, Modifier 25 and More…

Oncologists are getting hit with yet another one-two payment punch under a new national downcoding policy from Cigna.

E-Reimbursement SPECIAL EDITION–Medicare Physician Fee Schedule Final Rule 2026

Details are not yet available (and have not been officially posted), but the Continuing Resolution (“CR”) signed by President Trump yesterday will continue telehealth as it was, allowing patients to receive care at home. That’s the good news. The bad news is that it will only be restored until January 30th through this bill. If you have been holding telehealth claims, stay tuned.

State and National Legislative & Regulatory Issues

On October 31, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule (PFS) final rule for 2026. The rule finalizes physician reimbursement and policy reforms under the PFS as well as changes to reporting requirements and policy updates for the Quality Payment Program.

Last week, after agreeing to a deal to end the federal government shutdown, Congress passed a continuing resolution that would reopen the government, at least through January 30, 2026.  Within the continuing resolution package was an extension of the Medicare telehealth waivers, which had previously expired on October 1, 2025 (NOTE: The package contained several divisions, however the link provided in this newsletter only goes to the section containing the telehealth items).  In the passed legislation, the telehealth waivers that had expired will now be extended through January 30, 2026.

FDA Approvals

KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) Subcutaneous Injection 165 mg/ 2,000 units per mL is indicated for use in adult patients across most solid tumor indications for KEYTRUDA® (pembrolizumab) Injection 100 mg—whether alone or in combination with other therapies.

The Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM).

The U.S. Food and Drug Administration (FDA) has issued multiple safety updates affecting oncology drugs, including new labeling requirements for postapproval safety issues, Risk Evaluation and Mitigation Strategy (REMS) program changes, boxed warnings for CAR-T and chemotherapy agents, and mandatory genetic testing requirements to prevent fatal toxicities.

The Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

The Food and Drug Administration approved ziftomenib (Komzifti, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.

The Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021.

The Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024.

The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin.