Oncology Video Recap—February 16, 2026

This biweekly Oncology video recap is covering key developments across the cancer landscape. Highlights include regulatory decisions and review milestones, plus notable clinical progress and program designations. Updates span solid tumors and supportive platform expansions

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Week 2–8 February 2026
Weeks 9–15 February 2026

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Transcript

Welcome to the latest edition of Oncology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

In Canada, Novartis reported progress for Kisqali, also known as ribociclib. Kisqali is approved by Health Canada as of June 2025 for adjuvant treatment of hormone receptor positive, HER2-negative stage II to III early breast cancer at high risk of recurrence, in combination with an aromatase inhibitor. Canada’s Drug Agency, CDA-AMC, has now issued a positive draft recommendation supporting public reimbursement for eligible high-risk early breast cancer patients. If finalized, this could shape payer decisions and access across provinces.

In the United States, Relay Therapeutics announced that the FDA granted Breakthrough Therapy designation for zovegalisib, also called RLY-2608, in combination with fulvestrant. The designation applies to patients with PIK3CA-mutant, hormone receptor positive, HER2-negative advanced breast cancer whose disease has progressed after a CDK4/6 inhibitor, based on the company’s ReDiscover Phase 1/2 program. Breakthrough status may help accelerate development and review as additional data mature.

In Europe, AstraZeneca said the CHMP issued a positive opinion recommending approval of a perioperative Imfinzi regimen for resectable early gastric and gastroesophageal junction cancers. The recommendation is supported by MATTERHORN, a Phase 3 study with 948 patients, evaluating perioperative durvalumab plus FLOT chemotherapy versus chemotherapy alone in resectable stage II to IVA gastric or GEJ cancers. The CHMP cited event-free survival and overall survival benefit versus chemotherapy alone.

Also in the United States, Exelixis announced the FDA accepted for review a New Drug Application for zanzalintinib plus atezolizumab in previously treated metastatic colorectal cancer that is not MSI-high. The filing is based on STELLAR-303, a Phase 3 trial enrolling 901 patients that randomized zanzalintinib plus atezolizumab versus regorafenib. The FDA set a standard review PDUFA target action date of 03 Dec 2026.

Next, Krystal Biotech reported that the FDA granted Regenerative Medicine Advanced Therapy, or RMAT, designation to KB707 for advanced or metastatic non-small cell lung cancer. The company cited early clinical evidence from KYANITE-1, NCT06228326, evaluating inhaled KB707, described as a redosable immunotherapy aimed at localized IL-2 and IL-12 expression.

In Japan, Daiichi Sankyo announced an sNDA submission to the Ministry of Health, Labour and Welfare for DATROWAY, also known as datopotamab deruxtecan. The submission targets first-line metastatic triple-negative breast cancer in patients not eligible for immunotherapy, and is supported by TROPION-Breast02, a Phase 3 trial with 644 patients comparing DATROWAY versus investigator’s choice chemotherapy.

Back in the United States, Merck announced an FDA approval for pembrolizumab in platinum-resistant ovarian cancer. The FDA approved KEYTRUDA, and KEYTRUDA QLEX, in combination with paclitaxel with or without bevacizumab, for adults with PD-L1 positive disease defined as combined positive score, CPS, of at least 1. The indication covers platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after one or two prior systemic regimens. The approval is supported by KEYNOTE-B96, also called ENGOT-ov65, a Phase 3 study with 643 patients.

Finally, Biofrontera said the FDA accepted the filing of an sNDA for Ameluz photodynamic therapy for superficial basal cell carcinoma. Ameluz is aminolevulinic acid hydrochloride gel used with the RhodoLED red-light lamp, and it is currently approved in the United States for actinic keratosis. The FDA set a PDUFA target action date of 28 Sep 2026 for the superficial basal cell carcinoma submission.

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Why it matters

This set spans the full arc from payer access signals (Canada draft reimbursement) to regulatory decisions (FDA approval) and pipeline acceleration (BTD, RMAT, filing acceptances). [1], [2], [5], [7], [8]
CHMP support for a perioperative immunotherapy regimen in resectable gastric and GEJ cancer could shift EU treatment pathways if followed by an EC approval. [3]
Multiple PDUFA dates create near-term and mid-term catalysts for CRC and dermatology PDT platform expansion. [4], [8]
ADC competition remains active, with DATROWAY pursuing first-line metastatic TNBC in Japan for patients not eligible for immunotherapy. [6]

🗓️ Explore more details and sources

Week 2-8 February 2026
Weeks 9–15 February 2026

📚 See the full Oncology archive on our research hub page.

FAQ

1) What does a CDA-AMC positive draft recommendation mean for Kisqali (ribociclib, Novartis) access in Canada?

It is a preliminary signal supporting public reimbursement in the specified population, but final CDA-AMC guidance, pCPA negotiation, and provincial decisions still govern timing and breadth of access. [1]

2) What does FDA Breakthrough Therapy designation mean for zovegalisib (Relay Therapeutics)?

It is a development and review acceleration mechanism for serious diseases when early clinical evidence suggests substantial improvement over available therapy, it does not itself grant approval. [2]

3) What happens after CHMP recommends Imfinzi (durvalumab, AstraZeneca) for EU approval?

The European Commission reviews the CHMP opinion and, if it grants marketing authorization, the final label defines the approved population and regimen details. [3]

4) What is the key milestone in Exelixis’ zanzalintinib + atezolizumab filing?

FDA acceptance of the NDA initiates review and includes a stated PDUFA target action date of 03 Dec 2026 in the company release. [4]

5) What is RMAT, and what does it imply for KB707 (Krystal Biotech) in NSCLC?

RMAT is an FDA program intended to expedite development of eligible regenerative medicine therapies, with increased FDA interaction and flexibility options, approval still depends on confirmatory evidence. [5]

6) What is Daiichi Sankyo seeking for DATROWAY (datopotamab deruxtecan) in Japan?

An sNDA for first-line metastatic TNBC patients who are not candidates for immunotherapy, supported by TROPION-Breast02 results cited by the company. [6]

Entities / Keywords

Kisqali (ribociclib, Novartis), CDA-AMC, adjuvant, HR+/HER2- early breast cancer

Zovegalisib (RLY-2608, Relay Therapeutics), PI3Kα, PIK3CA-mutant, fulvestrant, Breakthrough Therapy designation

Imfinzi (durvalumab, AstraZeneca), CHMP, perioperative, FLOT, MATTERHORN, gastric cancer, GEJ cancer

Zanzalintinib (Exelixis), atezolizumab, metastatic colorectal cancer, NDA acceptance, PDUFA

KB707 (Krystal Biotech), RMAT, NSCLC, KYANITE-1

DATROWAY (datopotamab deruxtecan, Daiichi Sankyo), TROP2 ADC, TROPION-Breast02, MHLW, metastatic TNBC

KEYTRUDA / KEYTRUDA QLEX (pembrolizumab, Merck), platinum-resistant ovarian cancer, PD-L1 CPS ≥1, KEYNOTE-B96

Ameluz (aminolevulinic acid HCl, Biofrontera), photodynamic therapy, RhodoLED, superficial basal cell carcinoma, sNDA